(84 days)
Not Found
No
The description focuses on standard image processing techniques like registration, segmentation, normalization, and statistical analysis, without mentioning AI or ML algorithms.
No.
The device is image processing software designed to visualize lung ventilation and assist clinicians in interpreting MR images; it does not directly treat or prevent a disease or condition.
Yes
The device analyzes MR images to provide visualization and quantitative analysis of lung ventilation, which assists clinicians in the interpretation and numerical classification of images for diagnostic purposes.
Yes
The device description explicitly states "XENOVIEW VDP is image processing software" and "XENOVIEW VDP is an image analysis platform". The entire description focuses on the software's functions of loading, viewing, registering, segmenting, normalizing, and analyzing MR images. While it processes images generated by an MRI scanner, the device itself is the software performing the analysis.
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. They are used to examine these samples outside of the body.
- Device Function: The XENOVIEW VDP software analyzes medical images (MR images) of the lung. It processes these images to visualize and quantify lung ventilation. This is an analysis of data acquired from within the body (in vivo), not an analysis of a sample taken from the body (in vitro).
Therefore, while it is a medical device used in the diagnostic process, it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
XENOVIEW VDP is image processing software that analyzes a pulmonary hyperpolarized 129-Xe MR image and a proton chest MR image to provide visualization of lung ventilation in adults and pediatric patients aged 12 years and older.
Product codes
LLZ
Device Description
XENOVIEW VDP is an image analysis platform that quantifies normalized xenon intensity of a ventilated space using a pulmonary hyperpolarized 129-Xe ventilation MR image and accompanying proton chest MR image.
The XENOVIEW VDP image analysis process includes loading and viewing images, image registration and seqmentation, normalization and statistical analysis of 129Xe signal intensity distribution within the ventilation scan, and ultimately reporting the fraction of ventilated lunq volume as a percentage of thoracic cavity volume.
This software will be used by clinicians to assist in the interpretation and numerical classification of hyperpolarized 129-Xe ventilation MR images.
The HP 129Xe ventilation MR images are generated using an MRI scanner and appropriate RF chest coil with a patient that has inhaled XENOVIEW (xenon Xe 129 hyperpolarized).
The software provides a user-friendly interface and simple workflow that helps quide the user through the image analysis process, including the loading of images, registration of the anatomical image sets to the HP 129Xe image sets, segmentation of the lung, and automated classification of normalized ventilation distribution into multiple intensity levels via analysis of hyperpolarized 129Xe signal intensity within the segmented lung volume. The results of the image analysis are output as medical images of the classified ventilation, a summary report, and data files containing quantitative statistical analysis results.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
pulmonary hyperpolarized 129-Xe MR image and a proton chest MR image
Anatomical Site
lung / thoracic cavity
Indicated Patient Age Range
adults and pediatric patients aged 12 years and older
Intended User / Care Setting
clinicians
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)
The safety and performance of the XENOVIEW VDP software has been evaluated and verified in accordance with software specifications through software verification and validation testing per FDA's guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
December 23, 2022
Polarean, Inc. % Rita King CEO Methodsense, Inc. 1 Copley Pkwy, Ste. 410 Morrisville, North Carolina 27560
Re: K223071
Trade/Device Name: Xenoview VDP Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 29, 2022 Received: September 30, 2022
Dear Rita King:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223071
Device Name XENOVIEW VDP
Indications for Use (Describe)
XENOVIEW VDP is image processing software that analyzes a pulmonary hyperpolarized 129-Xe MR image and a proton chest MR image to provide visualization of lung ventilation in adults and pediatric patients aged 12 years and older.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Summary of 510(k)
Polarean, Inc K223071
This 510(k) Summary is in conformance with 21CFR 807.92
| Submitter: | Polarean, Inc.
PO Box 14805
Research Triangle Park, NC 27709-4805 |
|------------------|--------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO
MethodSense, Inc.
Email: ritaking@methodsense.com
Phone: 919-313-3961
Fax: 919-313-3979 |
| Company Contact: | Neil Wadehra
Title: VP of Operations
Email: nwadehra@polarean.com
Phone: (919) 206-7900 |
| Date Prepared: | September 30, 2022 |
Device Name and Classification
| Trade Name: | XENOVIEW VDP |
|---|---|
| Common Name: | Medical Imaging Software |
| Classification: | Class II |
| Regulation Number: | 21 CFR 892.2050 |
| Classification Panel: | Radiology |
LLZ
Product Code:
Predicate Device:
| Trade Name | THORACIC VCAR |
|---|---|
| Common Name | THORACIC VCAR |
| 510(k) Submitter / Holder | GE Healthcare, (GE Medical Systems LLC) |
| 510(k) Number | K103480 |
| Regulation Number | 21 CFR 892.2050 |
| Classification Panel | Picture Archiving and Communications |
| System | |
| Product Code | LLZ |
The predicate device has not been subject to a design-related recall.
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Device Description
XENOVIEW VDP is an image analysis platform that quantifies normalized xenon intensity of a ventilated space using a pulmonary hyperpolarized 129-Xe ventilation MR image and accompanying proton chest MR image.
The XENOVIEW VDP image analysis process includes loading and viewing images, image registration and seqmentation, normalization and statistical analysis of 129Xe signal intensity distribution within the ventilation scan, and ultimately reporting the fraction of ventilated lunq volume as a percentage of thoracic cavity volume.
This software will be used by clinicians to assist in the interpretation and numerical classification of hyperpolarized 129-Xe ventilation MR images.
The HP 129Xe ventilation MR images are generated using an MRI scanner and appropriate RF chest coil with a patient that has inhaled XENOVIEW (xenon Xe 129 hyperpolarized).
The software provides a user-friendly interface and simple workflow that helps quide the user through the image analysis process, including the loading of images, registration of the anatomical image sets to the HP 129Xe image sets, segmentation of the lung, and automated classification of normalized ventilation distribution into multiple intensity levels via analysis of hyperpolarized 129Xe signal intensity within the segmented lung volume. The results of the image analysis are output as medical images of the classified ventilation, a summary report, and data files containing quantitative statistical analysis results.
Indications for Use
XENOVIEW VDP is image processing software that analyzes a pulmonary hyperpolarized 129-Xe MR image and a proton chest MR image to provide visualization and evaluation of lung ventilation in adults and pediatric patients aged 12 years and older.
Substantial Equivalence
The Polarean XENOVIEW VDP is substantially equivalent to predicate device, the GE Medical Systems Thoracic VCAR (K103480) currently on the market.
The table below provides a detailed comparison of the Polarean XENOVIEW VDP software to the predicate device.
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Detailed Comparison of the Subject and Predicate Devices
| Characteristic | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| XENOVIEW VDP | Thoracic VCAR (K103480) | ||
| Intended Use / | |||
| Indications for Use | XENOVIEW VDP is an | ||
| image processing software | |||
| technology that analyzes a | |||
| pulmonary hyperpolarized | |||
| 129Xe MR image and a | |||
| proton chest MR image to | |||
| provide visualization and | |||
| evaluation of lung ventilation | |||
| in adults and pediatric | |||
| patients aged 12 years and | |||
| older | Thoracic VCAR is a CT, non- | ||
| invasive image analysis software | |||
| package, which may be used in | |||
| conjunction with CT lung images | |||
| to aid in the assessment of | |||
| thoracic disease diagnosis and | |||
| management. | |||
| The software will provide | |||
| automatic segmentation of the | |||
| lungs and automatic segmentation | |||
| and tracking of the airway tree. | |||
| The software will provide | |||
| quantification of Hounsfield units | |||
| and display by color the | |||
| thresholds within a segmented | |||
| region. | Identical intended use as both subject | ||
| and predicate device are non-invasive | |||
| image processing technologies of the | |||
| lung. | |||
| Equivalent indications for use as both | |||
| predicate and subject device provide | |||
| visualization and evaluation of the | |||
| lungs. | |||
| XENOVIEW VDP uses hyperpolarized | |||
| 129Xe MR images and proton MR | |||
| images, while Thoracic VCAR | |||
| (K103480) uses CT lung images. This | |||
| difference does not impact the | |||
| intended use of the device, and the | |||
| safety and effectiveness are | |||
| confirmed with testing. | |||
| Modality Supported | |||
| (MRI / CT) | MRI | CT | Different modality. The difference |
| does not impact the intended use of | |||
| the device, and the safety and | |||
| effectiveness are confirmed with | |||
| testing. | |||
| Characteristic | Subject Device | ||
| XENOVIEW VDP | Predicate Device | ||
| Thoracic VCAR (K103480) | Comparison | ||
| Lung Analysis | |||
| Performed | Yes – Entirety of lung is | ||
| analyzed by the software | Yes - Entirety of lung is analyzed | ||
| by the software; also, analysis of | |||
| Lobes, Airway, or user-defined | |||
| "zone", may be individually | |||
| analyzed by the software | Equivalent, with the difference being | ||
| that Thoracic VCAR (K103480) | |||
| performs additional analysis of the | |||
| individual lung lobes and the airway. | |||
| Input | |||
| Radiological Images | |||
| of the Lungs | Yes - Anatomical and xenon | ||
| images are registered | Yes - Anatomical image | Equivalent, with the difference being | |
| the number of images by each. This | |||
| difference does not impact the | |||
| intended use of the device, and the | |||
| safety and effectiveness are | |||
| confirmed with testing. | |||
| User Interface: | |||
| Screen Save | Yes | Yes | Identical |
| Window Level | Yes | Yes | Identical |
| Magnification | Yes | Yes | Identical |
| Dynamic rotation | Yes | Yes | Identical |
| User annotation | Yes | Yes | Identical |
| Simultaneous loading | |||
| of two studies | No – only one study may be | ||
| opened at once within the | |||
| XENOVIEW VDP program. | Yes – Two standard CT images | ||
| may be viewed at once within the | |||
| Thoracic VCAR program. | Different; XENOVIEW VDP does not | ||
| contain a feature to open multiple | |||
| studies within the same instance of | |||
| the program. | |||
| Image Functionality | |||
| Image Registration | Yes - Anatomical MR and | ||
| Xenon MR Images | No – CT Image Only | Different; additional registration | |
| functionality is needed due to | |||
| difference in modalities. This | |||
| difference does not impact the | |||
| intended use of the device, and the | |||
| safety and effectiveness are | |||
| confirmed with testing. | |||
| Characteristic | Subject Device | Predicate Device | Comparison |
| XENOVIEW VDP | Thoracic VCAR (K103480) | ||
| Automatic | |||
| Segmentation | Yes - Lung segmentation | Yes - Lung segmentation, lobe | |
| segmentation, airway | |||
| segmentation, and airway tracking | Equivalent, with the difference being | ||
| that Thoracic VCAR (K103480) | |||
| performs segmentation of additional | |||
| anatomical structures. | |||
| Manual | |||
| Segmentation | |||
| Adjustment | Yes - Lung segmentation | Yes - Lung segmentation, lobe | |
| segmentation, airway | |||
| segmentation, and airway tracking | Equivalent, with the difference being | ||
| that Thoracic VCAR (K103480) | |||
| performs segmentation of additional | |||
| anatomical structures. | |||
| Volume | |||
| Measurement | Yes - Thoracic Cavity | ||
| Volume | Yes - Thoracic Cavity Volume and | ||
| User-Defined Zone Volumes | Equivalent, with the difference being | ||
| that Thoracic VCAR (K103480) | |||
| additionally performs user-defined | |||
| zone volumes measurements. | |||
| Lung Volume | |||
| Rendering | Yes | Yes | Identical |
| Color Mapping | Yes - Color mapping of the | ||
| MR images from diagnostic | |||
| imaging agent 129 Xe. | Yes - Color mapping of the tissue | ||
| density from CT images. | Equivalent, with the difference being | ||
| that XENOVIEW VDP color mapping | |||
| is based on contrast of imaging from | |||
| 129Xe, while the Thoracic VCAR | |||
| (K103480) color mapping is based on | |||
| the tissue density obtained from of the | |||
| quantification of Hounsfield units | |||
| unique to CT scans. This difference | |||
| does not impact the intended use of | |||
| the device, and the safety and | |||
| effectiveness are confirmed with | |||
| testing. | |||
| Characteristic | Subject Device | Predicate Device | Comparison |
| XENOVIEW VDP | Thoracic VCAR (K103480) | ||
| Density Mapping by | |||
| User-Defined | |||
| Threshold | Yes - Lung Volume Fraction | Yes - Hounsfield Units | Equivalent, with the difference being |
| that the XENOVIEW VDP value for | |||
| threshold is defined by Xenon, while | |||
| the Thoracic VCAR (K103480) value | |||
| for threshold is defined by Hounsfield | |||
| Units. This difference does not impact | |||
| the intended use of the device, and | |||
| the safety and effectiveness are | |||
| confirmed with testing. | |||
| Statistics displayed | |||
| by lung | Yes - Bins calculated based | ||
| on Lung Volume Percentage | Yes - "Bins" or ranges of data | ||
| calculated by Hounsfield Units | Equivalent, with the difference being | ||
| that the XENOVIEW VDP value for | |||
| threshold is defined by Lung Volume | |||
| Fraction, while the Thoracic VCAR | |||
| (K103480) value for threshold is | |||
| defined by Hounsfield Units. This | |||
| difference does not impact the | |||
| intended use of the device, and the | |||
| safety and effectiveness are | |||
| confirmed with testing. | |||
| Image Measurement | |||
| Tool | Yes - Ruler tool available | Yes - Ruler / measurement tool | |
| available, explicit labeling of | |||
| various anatomical features | Equivalent, with the difference being | ||
| that the Thoracic VCAR (K103480) | |||
| user interface provides additional | |||
| functionality for measurements. | |||
| Simultaneous loading | |||
| of exams | No - Only one exam can be | ||
| opened at once for analysis | Yes - Multiple exams can be open | ||
| simultaneously for comparison | Different; XENOVIEW VDP does not | ||
| contain a feature to load multiple | |||
| exams within the same instance of the | |||
| program. | |||
| Characteristic | Subject Device | ||
| XENOVIEW VDP | Predicate Device | ||
| Thoracic VCAR (K103480) | Comparison | ||
| Save State | No - Save to files without | ||
| ability to restore sessions | Yes - Ability to save and restore at | ||
| any time the current work for | |||
| staged analysis | Different; XENOVIEW VDP does not | ||
| contain a feature to re-open a | |||
| previous work session. | |||
| Reporting capabilities | Yes - Medical report | ||
| available for clinical analysis | Yes - Medical report available for | ||
| clinical analysis | Identical |
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Summary of Non-Clinical Testing
The safety and performance of the XENOVIEW VDP software has been evaluated and verified in accordance with software specifications through software verification and validation testing per FDA's guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).
Summary of Clinical Testing
XENOVIEW VDP did not require clinical studies to support substantial equivalence.
Conclusion
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics, and performance testing, the XENOVIEW VDP software raises no new questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety and effectiveness.