Who is the manufacturer of Rayvolve PTX-PE?

AZmed filed the 510(k) submission for Rayvolve PTX-PE (K243808).

What is the FDA product code for Rayvolve PTX-PE?

QFM. It is classified under 21 CFR 892.2080 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Rayvolve PTX-PE?

510(k) clearance (submission type: Traditional).

Does Rayvolve PTX-PE use AI or machine learning?

Yes. Rayvolve PTX-PE (K243808) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for Rayvolve PTX-PE?

Lunit INSIGHT CXR Triage (K211733).

Who can help prepare an FDA 510(k) submission like Rayvolve PTX-PE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Rayvolve PTX-PE get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Rayvolve PTX-PE

K243808 · AZmed · QFM · Mar 21, 2025 · Radiology

Device Facts

Record ID	K243808
Device Name	Rayvolve PTX-PE
Applicant	AZmed
Product Code	QFM · Radiology
Decision Date	Mar 21, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2080
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

Rayvolve PTX-PE is a radiological computer-assisted triage and notification software that analyzes chest x-ray images (Postero-Anterior (PA) or Antero-Posterior (AP)) of patients 18 years of age or older for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). Rayvolve PTX-PE uses an artificial intelligence algorithm to analyze the images for features suggestive of critical findings and provides study-level output available in DICOM Node Servers for worklist prioritization or triage. As a passive notification for prioritization-only software tool within the standard of care workflow, Rayvolve PTX-PE does not send a proactive alert directly to a trained medical specialist. Rayvolve PTX-PE is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making.

Device Story

Software-only device; analyzes chest X-ray images (PA/AP) for pleural effusion and pneumothorax. Uses AI algorithm to detect features suggestive of critical findings; provides study-level output to DICOM node servers/PACS for worklist prioritization. Used in clinical settings by healthcare professionals. Operates via cloud platform connected to local network/DICOM node server. Passive notification tool; does not alert specialists directly; no image markup. Results assist in workflow prioritization; do not replace physician interpretation. Benefits include improved triage efficiency for critical findings.

Clinical Evidence

Bench testing only. Standalone performance assessment using 2,000 radiographs (1,000 pneumothorax, 1,000 pleural effusion). Pneumothorax: AUC 0.9857, sensitivity 0.9379, specificity 0.9178. Pleural effusion: AUC 0.9830, sensitivity 0.9134, specificity 0.9448. Performance consistent across age, gender, ethnicity, projection views, and patient position.

Technological Characteristics

Software-only; DICOM-compliant; cloud-deployed; networked via DICOM node servers/PACS. AI-based algorithm for image analysis. No physical materials. Moderate level of concern.

Indications for Use

Indicated for patients 18 years of age or older to analyze PA or AP chest X-ray images for suspected pleural effusion and/or pneumothorax. Not for stand-alone clinical decision-making; not for directing attention to specific image portions.

Regulatory Classification

Identification

Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.

Special Controls

Radiological computer aided triage and notification software must comply with the following special controls: 1. Design verification and validation must include: i. A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations. ii. A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (e.g., improved time to review of prioritized images for pre-specified clinicians). iii. Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment. iv. Standalone performance testing protocols and results of the device. v. Appropriate software documentation (e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results). 2. Labeling must include the following: i. A detailed description of the patient population for which the device is indicated for use. ii. A detailed description of the intended user and user training that addresses appropriate use protocols for the device. iii. Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (e.g., poor image quality for certain subpopulations), as applicable. iv. A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images. v. Device operating instructions. vi. A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.

*Classification.* Class II (special controls). The special controls for this device are:(1) Design verification and validation must include: (i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations. (ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage ( *e.g.,* improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts ( *e.g.,* subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone performance testing protocols and results of the device. (v) Appropriate software documentation ( *e.g.,* device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following: (i) A detailed description of the patient population for which the device is indicated for use; (ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device; (iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level ( *e.g.,* poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images; (v) Device operating instructions; and (vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness ( *e.g.,* improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (*e.g.,* confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.

Predicate Devices

Lunit INSIGHT CXR Triage (K211733)

Related Devices

K211733 — Lunit INSIGHT CXR Triage · Lunit, Inc. · Nov 10, 2021
K230899 — qXR-PTX-PE · Qure.Ai Technologies · Aug 22, 2023
K232410 — SmartChest · Milvue · May 10, 2024
K191556 — Red Dot · Behold.Ai Technologies Limited · Feb 28, 2020
K213941 — Annalise Enterprise CXR Triage Pneumothorax · Annalise-Ai · Feb 24, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ March 21, 2025 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. AZmed Anthony Joseph QARA Associate 10 Rue d'Uzès Paris, 75002 France Re: K243808 Trade/Device Name: Rayvolve PTX-PE Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological Computer Aided Triage And Notification Software Regulatory Class: Class II Product Code: QFM Dated: February 17, 2025 Received: February 18, 2025 Dear Anthony Joseph: 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 (the 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 available 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. {1}------------------------------------------------ Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/medical {2}------------------------------------------------ devices/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, Jessica Lamb Jessica Lamb Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K 243808 | |----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Please provide the device trade name(s). | Rayvolve (Rayvolve PTX-PE) | | Please provide your Indications for Use below. | | Rayvolve PTX-PE is a radiological computer-assisted triage and notification software that analyzes chest x-ray images (Postero-Anterior (PA) or Antero-Posterior (AP)) of patients 18 years of age or older for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). Rayvolve PTX-PE uses an artificial intelligence algorithm to analyze the images for features suggestive of critical findings and provides study-level output available in DICOM node servers for worklist prioritization or triage. As a passive notification for prioritization-only software tool within the standard of care workflow, Rayvolve PTX-PE does not send a proactive alert directly to a trained medical specialist. Rayvolve PTX-PE is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making. | Please select the types of uses (select one or both, as applicable). | <svg height="12" width="12"> <rect height="12" style="fill:none;stroke-width:2;stroke:black" width="12"></rect> <line style="stroke:black;stroke-width:2" x1="0" x2="12" y1="0" y2="12"></line> <line style="stroke:black;stroke-width:2" x1="0" x2="12" y1="12" y2="0"></line> </svg> Prescription Use (Part 21 CFR 801 Subpart D) <svg height="12" width="12"> <rect height="12" style="fill:none;stroke-width:2;stroke:black" width="12"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the alphanumeric string "K243808" in a simple, sans-serif font. The characters are uniformly sized and spaced, with a clear distinction between the letter "K" and the numerical digits that follow. The text is presented in black against a plain white background, ensuring high contrast and readability. Image /page/4/Picture/1 description: The image shows the word "azmed" in a dark blue sans-serif font. The letters are closely spaced together, and the "a" and "z" are stylized with a diagonal line running through them. The word is centered and appears to be a logo or brand name. ## RAYVOLVE PTX-PE 510K Summary {5}------------------------------------------------ ## Content | 1. Submitter | 3 | |-------------------------------------------------|----| | 2. Device identification | 3 | | 3. Predicate device | 3 | | 4. Device description | 4 | | 5. Intended use/Indication for use | 5 | | 6. Substantial equivalence Discussion | 5 | | 7. Performance data summary | 11 | | a. Software verification and validation testing | 11 | | b. Bench Testing | 12 | | 8. CONCLUSION | 13 | {6}------------------------------------------------ ## 1. Submitter Submitted date: 2025-02-17 | Submitter | AZmed 10 Rue d'Uzès 75002 Paris, France Phone: +33 6 72 19 04 19 | |----------------|--------------------------------------------------------------------------------------------------------------------------------| | Contact person | Anthony JOSEPH QARA Associate 10 Rue d'Uzès 75002 Paris, France Phone: +33 6 72 19 04 19 Mail: anthony@azmed.co | ### 2. Device identification | Name of the Device | Common or Usual Name | Regulatory section | Classification | Product Code | Panel | |-----------------------|----------------------------|-----------------------|----------------|-----------------|-------------------| | Rayvolve PTX-PE | Rayvolve | 21 CFR 892.2080 | Class II | QFM | 90 (Radiology) | ## 3. Predicate device The legally marketed device for which AZmed is claiming equivalence is identified as follows: | Manufacturer | Product Name | 510K Number | |--------------|-----------------------------|-------------| | Lunit, Inc. | Lunit INSIGHT CXR Triage | K211733 | {7}------------------------------------------------ ## 4. Device description Rayvolve PTX-PE is a software-only device designed to help healthcare professionals. It's a radiological computer-assisted triage and notification software that analyzes chest x-ray imaqes (Postero-Anterior (PA) or Antero-Posterior (AP)) of patients of 18 years of age or older for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). It is intended to work in combination with DICOM node servers. Rayvolve PTX-PE has been developed to use the current edition of the DICOM image standard. DICOM is the international standard for transmitting, storing, retrieving, printing, processing, and displaying medical imaging. Using the DICOM standard allows Rayvolve PTX-PE to interact with existing DICOM node servers (eg .: PACS), and clinical-grade image viewers. The device is designed to run on a cloud platform and be connected to the radiology center's local network. It can also interact with the DICOM Node server. When remotely connected to a medical center DICOM Node server, the software utilizes Al-based analysis algorithms to analyze chest X-rays for features suggestive of critical findings and provide study-level outputs to the DICOM node server for worklist prioritization. Following receipt of chest X-rays, the software device automatically analyzes each image to detect features suggestive of pneumothorax and/or pleural effusion. Rayvolve PTX-PE filters and downloads only X-rays with organs determined from the DICOM Node server. As a passive notification for prioritization-only software tool within the standard of care workflow, Rayvolve PTX-PE does not send a proactive alert directly to a trained health professional. Rayvolve PTX-PE is not intended to direct attention to a specific portion of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making. Rayvolve PTX-PE does not intend to replace medical doctors. The instructions for use are strictly and systematically transmitted to each user and used to train them on Rayvolve's use. ### 5. Intended use/Indication for use Rayvolve PTX-PE is a radiological computer-assisted triage and notification software that analyzes chest x-ray images (Postero-Anterior (PA) or Antero-Posterior (AP)) of patients of 18 years of age or older for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). Rayvolve PTX-PE uses an artificial intelligence algorithm to analyze the images for {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "azmed" in a stylized, sans-serif font. The letters are a dark blue color, and the background is white. The "z" in the word is unique, with a diagonal line that extends beyond the top and bottom of the letter. features suggestive of critical findings and provides study-level output available in the PACS (or other DICOM storage platforms) for worklist prioritization or triage. As a passive notification for prioritization-only software tool within the standard of care workflow, Rayvolve PTX-PE does not send a proactive alert directly to a trained medical specialist. Rayvolve PTX-PE is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making. #### Substantial equivalence Discussion 6. The comparison chart below provides evidence to facilitate the substantial equivalence determination between Rayvolve PTX-PE to the predicate device (K211733) concerning the intended use, technological characteristics, and principle of operation vice and the cited predicate device. | Comparison to predicate device | Lunit INSIGHT CXR Triage - Predicate (K220164) | Rayvolve PTX-PE - Subject device 510(k) file | Comparison to the predicate | |-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Lunit INSIGHT CXR Triage | Rayvolve | N/A | | Manufacturer | Lunit, Inc. | AZmed | N/A | | 510 (k) # | K211733 | K243808 | N/A | | Regulation Number | 21 CFR 892.2080 | 21 CFR 892.2080 | Same | | Class | II | II | Same | | Product Code | QFM | QFM | Same | | Device Panel | Radiology | Radiology | Same | | Level of Concern | Moderate | Moderate | Same | | Intended use / Indications for use | Lunit INSIGHT CXR Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings | Rayvolve PTX-PE is a radiological computer-assisted triage and notification software that analyzes chest x-ray images (Postero-Anterior (PA) or Antero-Posterior (AP)) of patients 18 years | Equivalent, slight precision on the intended patient population (see the line 'intended | | Comparison to predicate device | Lunit INSIGHT CXR Triage - Predicate (K220164) | Rayvolve PTX-PE - Subject device 510(k) file | Comparison to the predicate | | | (pleural effusion and/or pneumothorax). Lunit INSIGHT CXR Triage uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization or triage. As a passive notification for prioritization-only software tool within standard of care workflow, Lunit INSIGHT CXR Triage does not send a proactive alert directly to the appropriately trained medical specialists. Lunit INSIGHT CXR Triage is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making. | of age or older for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). Rayvolve PTX-PE uses an artificial intelligence algorithm to analyze the images for features suggestive of critical findings and provides study-level output available in DICOM Node Servers for worklist prioritization or triage. As a passive notification for prioritization-only software tool within the standard of care workflow, Rayvolve PTX-PE does not send a proactive alert directly to a trained medical specialist. Rayvolve PTX-PE is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making. | patient population for the justification) and for other DICOM storage platforms the subject device. Other DICOM storage platforms are equivalent to PACS. None of those precisions raise new questions of safety or effectiveness | | Intended user | Appropriately trained medical specialists who are qualified to interpret chest radiographs | Healthcare professionals | Equivalent. Healthcare professionals are qualified to interpret chest radiographs | | Intended patient population | Adults | 18 years of age or older | Equivalent: Our dataset contains images for patients of | | Comparison to predicate device | Lunit INSIGHT CXR Triage - Predicate (K220164) | Rayvolve PTX-PE - Subject device 510(k) file | Comparison to the predicate | | | | | 18-21 years old. The performance results (see Appendix 25) shows that the performances of Rayvolve PTX-PE for patients between 18 and 21 years old are equivalent to the results obtained for patients older than 21 years old. So, it doesn't raise new questions of safety or effectiveness, and maintain the same level of performance than the predicated device | | Targeted clinical condition and anatomy | Pleural effusion, pneumothorax Chest/Lung | Pleural effusion, pneumothorax Chest/Lung | Same | | Radiological images format | DICOM | DICOM | Same | | Image modality | Frontal chest X-ray | Postero-Anterior (PA) or Antero-Posterior (AP) chest X-ray | Equivalent. Inclusion of the orientation of the image | | Comparison to predicate device | Lunit INSIGHT CXR Triage - Predicate (K220164) | Rayvolve PTX-PE - Subject device 510(k) file | Comparison to the predicate | | | | | acquisition, but the performance testing (see appendix 25) has demonstrated that Rayvolve PTX-PE achieves equivalent accuracy on both AP and PA views, so considering both views doesn't raise new questions of safety or effectiveness, and maintain the same level of performance than the predicated device | | Algorithm for pre-specified critical findings detection | Al algorithm designed to detect pleural effusion and pneumothorax in chest X-ray images. Lunit INSIGHT CXR Triage uses a vendor agnostic algorithm compatible with DICOM chest X-ray images. | Al algorithm designed to detect pleural effusion and pneumothorax in chest X-ray images. Rayvolve PTX-PE uses a vendor agnostic algorithm compatible with DICOM chest X-ray images. | Same | | Where generated results are stored | PACS/Workstation | PACS/Workstation | Same | | Comparison to predicate device | Lunit INSIGHT CXR Triage - Predicate (K220164) | Rayvolve PTX-PE - Subject device 510(k) file | Comparison to the predicate | | Computationa l platform | Lunit INSIGHT CXR Triage is designed as a software module that can be deployed on several computing and X-ray imaging platforms such as radiological imaging equipment, PACS, On Premise or On Cloud. | Rayvolve PTX-PE is designed as a software module that can be deployed on several computing and X-ray imaging platforms such as radiological imaging equipment, PACS, On Premise or On Cloud. | Same | | Device output in case of positive detection | When deployed on other radiological imaging equipment Lunit INSIGHT CXR Triage automatically runs after image acquisition and prioritizes and displays the analysis result through the worklist interface of PACS/workstation. No markup on original image. Secondary capture of the finding. Upon image acquisition from other radiological imaging equipment (e.g. X-ray systems), an on-device, tehcnologist notification indicating which cases were flagged by Lunit INSIGHT CXR Triage in PACS, is generated 15 minutes after interpretation by the user. The on device notification is contextual and does not provide any diagnostic | When deployed on other radiological imaging equipment Rayvolve PTX-PE automatically runs after image acquisition and prioritizes and displays the analysis result through the worklist interface of PACS/workstation. No markup on the original image. Secondary capture of the device will indicate the presence of findings suspicious of pneumothorax or pleural effusion. Upon image acquisition from other radiological imaging equipment (e.g, X-ray systems), a passive notification indicating which studies were flagged by Rayvolve PTX-PE is generated. The notification is | Same | | Comparison to predicate device | Lunit INSIGHT CXR Triage - Predicate (K220164) | Rayvolve PTX-PE - Subject device 510(k) file | Comparison to the predicate | | | information. It is not intended to inform any clinical decision, prioritization, or action to the technologist. | contextual and does not provide any diagnostic information. It is not intended to inform any clinical decision, prioritization, or action. | | | Notification (i.e., recipient timing and means of notification) | Passive notification. Images with suspicion of pleural effusion and/or pneumothorax are flagged in PACS/workstation | Passive notification. Images with suspicion of pneumothorax and/or pleural effusion are flagged in PACS/workstation/DICOM viewer. | Equivalent: DICOM viewers are the software that allow to open the Dicom files on the workstations, it doesn't raise new questions of safety or effectiveness | | Performance level - Timing of notification | The average time taken by the device to analyze the study and send a notification to the worklist is 20,76 seconds for pleural effusion and 20.45 seconds for pneumothorax…