(84 days)
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.
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.
The provided document is a 510(k) Premarket Notification from the FDA, seeking substantial equivalence for the XENOVIEW VDP device. While it summarizes non-clinical testing for software verification and validation, it explicitly states that clinical studies were not required. Therefore, the document does not contain the detailed clinical study information requested to describe acceptance criteria and proof of performance through clinical trials.
The document focuses on demonstrating substantial equivalence to a predicate device (GE Medical Systems Thoracic VCAR K103480) based on technological characteristics and non-clinical performance.
Here's an analysis based on the information provided in the document, and what is missing:
The document states:
- "Summary of Clinical Testing: XENOVIEW VDP did not require clinical studies to support substantial equivalence."
This immediately indicates that information regarding a clinical study proving the device meets specific acceptance criteria as you've requested (e.g., sample size, expert consensus, MRMC studies, specific performance metrics against ground truth from a clinical study) will not be present.
Therefore, for aspects relating to clinical study data, such as a table of acceptance criteria met by a clinical study, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance from a clinical study, the answer is that this information is not available in the provided text because clinical studies were not required for this 510(k) submission.
The "acceptance criteria" discussed in this document pertain to the software verification and validation testing and demonstration of substantial equivalence to a predicate device, not performance within a clinical setting.
However, I can still address the aspects for which information is provided or implied by the nature of a 510(k) submission not requiring clinical trials:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (from a 510(k) perspective for software verification/validation): The document relies on "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)." This guidance typically involves demonstrating that the software functions as intended and meets its specifications, including requirements for accuracy, reliability, and security of its image processing functions. Specific quantitative performance metrics for disease detection accuracy against clinical ground truth are not provided because a clinical study was not conducted or required.
- Reported Device Performance: The document states, "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." No specific numerical performance metrics (e.g., sensitivity, specificity, accuracy for a clinical outcome) are reported as this was not a clinical trial. The performance reported here refers to the successful completion of engineering validation tests.
2. Sample size used for the test set and the data provenance:
- Clinical Test Set: Not applicable/not provided, as clinical studies were not required.
- Software Verification/Validation Test Set: The document does not specify the sample size or provenance of data used for the software verification and validation tests. This type of detail is typically found in the full 510(k) submission, not the public summary letter. These tests would likely use a combination of synthetic, historical, or internally generated data to test functionality, robustness, and accuracy of image processing steps (e.g., registration, segmentation, quantification of xenon intensity). Provenance might be internal datasets or publicly available phantom/synthetic data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Clinical Test Set: Not applicable/not provided, as clinical studies were not required. For software verification, ground truth would likely be established by engineering specifications, known inputs, or validated reference images, rather than clinical experts.
4. Adjudication method for the test set:
- Clinical Test Set: Not applicable/not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. The document explicitly states that "XENOVIEW VDP did not require clinical studies to support substantial equivalence." An MRMC study is a type of clinical study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Clinical Standalone Performance: Not applicable/not provided. The document describes the device as "image processing software that analyzes a pulmonary hyperpolarized 129-Xe MR image and a proton chest MR image to provide visualization of lung ventilation." Its function is to assist clinicians, not to make a diagnosis independently. While its internal algorithms perform computations "standalone," the performance evaluation described here (non-clinical) does not speak to its standalone diagnostic performance in a clinical context.
7. The type of ground truth used:
- Clinical Trial Ground Truth: Not applicable/not provided.
- Software Verification/Validation Ground Truth: For the non-clinical software verification and validation, ground truth would be based on "software specifications." This means the expected outcome of processing an image (e.g., correct segmentation mask, accurate numerical quantification of xenon intensity per voxel/region) is predefined based on the design requirements and validated algorithms. This is not derived from expert clinical consensus, pathology, or patient outcomes data as it would be in a clinical study.
8. The sample size for the training set:
- Not provided. The document describes a medical device (software for image processing), focusing on its functionality and equivalence, not an AI/ML model for which a distinct "training set" would typically be discussed in a submission. While the software likely uses algorithms that were developed or "trained" at some point (e.g., for image registration or segmentation), the FDA submission for this device (XENOVIEW VDP) does not provide details on a specific training dataset from a machine learning perspective. It's listed as a "Medical Imaging Software" (K223071), not explicitly as an AI/ML device in the way recent submissions are categorized.
9. How the ground truth for the training set was established:
- Not provided. As above, the summary does not detail the training or ground truth for internal algorithms, focusing instead on the external validation of the software's functionality and performance against its specifications.
In summary, the provided FDA 510(k) letter for XENOVIEW VDP establishes substantial equivalence based on non-clinical software verification and validation testing in accordance with FDA guidance, and a comparison of technological characteristics to a predicate device. It explicitly states that clinical studies were not required or performed for this submission. Therefore, the detailed clinical study-related information requested (e.g., acceptance criteria confirmed by clinical data, sample sizes from clinical trials, expert ground truth for clinical cases, MRMC studies) is not present in the document.
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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 14805Research Triangle Park, NC 27709-4805 |
|---|---|
| Primary Contact: | Rita King, CEOMethodSense, Inc.Email: ritaking@methodsense.comPhone: 919-313-3961Fax: 919-313-3979 |
| Company Contact: | Neil WadehraTitle: VP of OperationsEmail: nwadehra@polarean.comPhone: (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 animage processing softwaretechnology that analyzes apulmonary hyperpolarized129Xe MR image and aproton chest MR image toprovide visualization andevaluation of lung ventilationin adults and pediatricpatients aged 12 years andolder | Thoracic VCAR is a CT, non-invasive image analysis softwarepackage, which may be used inconjunction with CT lung imagesto aid in the assessment ofthoracic disease diagnosis andmanagement.The software will provideautomatic segmentation of thelungs and automatic segmentationand tracking of the airway tree.The software will providequantification of Hounsfield unitsand display by color thethresholds within a segmentedregion. | Identical intended use as both subjectand predicate device are non-invasiveimage processing technologies of thelung.Equivalent indications for use as bothpredicate and subject device providevisualization and evaluation of thelungs.XENOVIEW VDP uses hyperpolarized129Xe MR images and proton MRimages, while Thoracic VCAR(K103480) uses CT lung images. Thisdifference does not impact theintended use of the device, and thesafety and effectiveness areconfirmed with testing. |
| Modality Supported(MRI / CT) | MRI | CT | Different modality. The differencedoes not impact the intended use ofthe device, and the safety andeffectiveness are confirmed withtesting. |
| Characteristic | Subject DeviceXENOVIEW VDP | Predicate DeviceThoracic VCAR (K103480) | Comparison |
| Lung AnalysisPerformed | Yes – Entirety of lung isanalyzed by the software | Yes - Entirety of lung is analyzedby the software; also, analysis ofLobes, Airway, or user-defined"zone", may be individuallyanalyzed by the software | Equivalent, with the difference beingthat Thoracic VCAR (K103480)performs additional analysis of theindividual lung lobes and the airway. |
| InputRadiological Imagesof the Lungs | Yes - Anatomical and xenonimages are registered | Yes - Anatomical image | Equivalent, with the difference beingthe number of images by each. Thisdifference does not impact theintended use of the device, and thesafety and effectiveness areconfirmed 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 loadingof two studies | No – only one study may beopened at once within theXENOVIEW VDP program. | Yes – Two standard CT imagesmay be viewed at once within theThoracic VCAR program. | Different; XENOVIEW VDP does notcontain a feature to open multiplestudies within the same instance ofthe program. |
| Image Functionality | |||
| Image Registration | Yes - Anatomical MR andXenon MR Images | No – CT Image Only | Different; additional registrationfunctionality is needed due todifference in modalities. Thisdifference does not impact theintended use of the device, and thesafety and effectiveness areconfirmed with testing. |
| Characteristic | Subject Device | Predicate Device | Comparison |
| XENOVIEW VDP | Thoracic VCAR (K103480) | ||
| AutomaticSegmentation | Yes - Lung segmentation | Yes - Lung segmentation, lobesegmentation, airwaysegmentation, and airway tracking | Equivalent, with the difference beingthat Thoracic VCAR (K103480)performs segmentation of additionalanatomical structures. |
| ManualSegmentationAdjustment | Yes - Lung segmentation | Yes - Lung segmentation, lobesegmentation, airwaysegmentation, and airway tracking | Equivalent, with the difference beingthat Thoracic VCAR (K103480)performs segmentation of additionalanatomical structures. |
| VolumeMeasurement | Yes - Thoracic CavityVolume | Yes - Thoracic Cavity Volume andUser-Defined Zone Volumes | Equivalent, with the difference beingthat Thoracic VCAR (K103480)additionally performs user-definedzone volumes measurements. |
| Lung VolumeRendering | Yes | Yes | Identical |
| Color Mapping | Yes - Color mapping of theMR images from diagnosticimaging agent 129 Xe. | Yes - Color mapping of the tissuedensity from CT images. | Equivalent, with the difference beingthat XENOVIEW VDP color mappingis based on contrast of imaging from129Xe, while the Thoracic VCAR(K103480) color mapping is based onthe tissue density obtained from of thequantification of Hounsfield unitsunique to CT scans. This differencedoes not impact the intended use ofthe device, and the safety andeffectiveness are confirmed withtesting. |
| Characteristic | Subject Device | Predicate Device | Comparison |
| XENOVIEW VDP | Thoracic VCAR (K103480) | ||
| Density Mapping byUser-DefinedThreshold | Yes - Lung Volume Fraction | Yes - Hounsfield Units | Equivalent, with the difference beingthat the XENOVIEW VDP value forthreshold is defined by Xenon, whilethe Thoracic VCAR (K103480) valuefor threshold is defined by HounsfieldUnits. This difference does not impactthe intended use of the device, andthe safety and effectiveness areconfirmed with testing. |
| Statistics displayedby lung | Yes - Bins calculated basedon Lung Volume Percentage | Yes - "Bins" or ranges of datacalculated by Hounsfield Units | Equivalent, with the difference beingthat the XENOVIEW VDP value forthreshold is defined by Lung VolumeFraction, while the Thoracic VCAR(K103480) value for threshold isdefined by Hounsfield Units. Thisdifference does not impact theintended use of the device, and thesafety and effectiveness areconfirmed with testing. |
| Image MeasurementTool | Yes - Ruler tool available | Yes - Ruler / measurement toolavailable, explicit labeling ofvarious anatomical features | Equivalent, with the difference beingthat the Thoracic VCAR (K103480)user interface provides additionalfunctionality for measurements. |
| Simultaneous loadingof exams | No - Only one exam can beopened at once for analysis | Yes - Multiple exams can be opensimultaneously for comparison | Different; XENOVIEW VDP does notcontain a feature to load multipleexams within the same instance of theprogram. |
| Characteristic | Subject DeviceXENOVIEW VDP | Predicate DeviceThoracic VCAR (K103480) | Comparison |
| Save State | No - Save to files withoutability to restore sessions | Yes - Ability to save and restore atany time the current work forstaged analysis | Different; XENOVIEW VDP does notcontain a feature to re-open aprevious work session. |
| Reporting capabilities | Yes - Medical reportavailable for clinical analysis | Yes - Medical report available forclinical 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.
§ 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).