IQ-UIP

K242467 · Imbio, Inc. · QWO · Dec 19, 2024 · Radiology

Device Facts

• Record ID: K242467
• Device Name: IQ-UIP
• Applicant: Imbio, Inc.
• Product Code: QWO · Radiology
• Decision Date: Dec 19, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2085
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

Imbio IQ-UIP is a computer-aided software indicated for use in passively notifying specialists associated with interstitial lung disease (ILD) centers of radiological findings suggestive of radiological usual interstitial pneumonia (UIP) in non-contrast, chest CT scans of adults. Imbio IQ-UIP uses an artificial intelligence algorithm to analyze images and identify positive findings on a worklist application separate from and in parallel to the standard of care radiological image interpretation. Identification of positive findings include summary reports with a clinical guideline reference for the definition of UIP pattern that are meant for informational purposes only. The device does not alter the original medical image and is not intended to be used as a diagnostic device. The results of Imbio IQ-UIP are used to notify specialists at an ILD center of radiological findings that may be consistent with UIP. These specialists are qualified clinicians experienced in evaluating chest CTs for ILD. Input images originate from within the same hospital network associated with the ILD center. The results of Imbio IQ-UIP are intended to be used in conjunction with additional patient information and based on the user's professional judgment, to assist with the review of medical images. Notified clinicians are responsible for viewing full image series and making final clinical determinations.

Device Story

IQ-UIP is a computer-aided software for passive notification of radiological findings suggestive of UIP in non-contrast chest CT scans. It utilizes a deep learning inference model to analyze volumetric CT images; identifies positive findings; generates summary reports with clinical guideline references. Operates in parallel to standard-of-care radiological interpretation; results displayed on a dedicated worklist application. Used by specialists at ILD centers; clinicians review full image series and apply professional judgment for final clinical determinations. Does not alter original medical images; not a diagnostic device. Benefits include alerting specialists to potential UIP patterns to assist in clinical review and workflow prioritization.

Clinical Evidence

Standalone performance assessment using 804 retrospective, multi-center, volumetric chest CT scans. Ground truth established by five U.S. board-certified radiologists with 5+ years of ILD experience. Primary endpoint: AUC ROC 96.6 [95.4, 97.7]; PPV 77.9 [73.3, 82.8]. Secondary endpoints: Sensitivity 90.2 [86.2, 94.3]; Specificity 91.5 [89.2, 93.7]. Prevalence of UIP+ pattern in cohort was 24.0%.

Technological Characteristics

Software-only device. Operates on non-contrast chest CT images (DICOM). Utilizes a deep learning inference model for image analysis. No hardware components. No patient contact (biocompatibility not applicable). Connectivity via hospital network integration. Software documentation level: Basic.

Indications for Use

Indicated for adults > 22 years old. Used to passively notify specialists at ILD centers of radiological findings suggestive of usual interstitial pneumonia (UIP) in non-contrast chest CT scans. Not for diagnostic use; intended as an adjunct to clinical judgment.

Regulatory Classification

Identification

Fibresolve is a software-only device that receives and analyzes lung computed tomography (CT) imaging data in order to provide a diagnostic subtype classification in suspected cases of interstitial lung disease (ILD). The device supplements the standard-of-care workflow by providing a qualitative, diagnostic classification output of imaging findings based on machine learning pattern recognition, in order to provide adjunctive information as part of a referral pathway to an appropriate Multidisciplinary Discussion (MDD) or as part of an MDD. Specifically, the tool is used to serve as an adjunct in the diagnosis of idiopathic pulmonary fibrosis (IPF) prior to invasive testing.

Special Controls

In combination with the general controls of the FD&C Act, radiology software for referral of findings related to fibrotic lung disease is subject to the following special controls:

Predicate Devices

• Fibresolve (DEN220040)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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, which 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.

Imbio. Inc. William Mclain QA/RA Manager 1015 Glenwood Avenue Floor 4 Minneapolis, Minnesota 55405

December 19, 2024

Re: K242467

Trade/Device Name: IQ-UIP Regulation Number: 21 CFR 892.2085 Regulation Name: Radiology software for referral of findings related to fibrotic lung disease Regulatory Class: Class II Product Code: QWO Dated: November 18, 2024 Received: November 18, 2024

Dear William Mclain:

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.

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"

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(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 (QS) 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/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-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products 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

Submission Number (if known)

K242467

Device Name

IQ-UIP

Indications for Use (Describe)

Imbio IQ-UIP is a computer-aided software indicated for use in passively notifying specialists associated with interstitial lung disease (ILD) centers of radiological findings suggestive of radiological usual interstitial pneumonia (UIP) in non-contrast, chest CT scans of adults. Imbio IQ-UIP uses an artificial intelligence algorithm to analyze images and identify positive findings on a worklist application separate from and in parallel to the standard of care radiological image interpretation. Identification of positive findings include summary reports with a clinical guideline reference for the definition of UIP pattern that are meant for informational purposes only. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of Imbio IQ-UIP are used to notify specialists at an ILD center of radiological findings that may be consistent with UIP. These specialists are qualified clinicians experienced in evaluating chest CTs for ILD. Input images originate from within the same hospital network associated with the ILD center. The results of Imbio IQ-UIP are intended to be used in conjunction with additional patient information and based on the user's professional judgment, to assist with the review of medical images. Notified clinicians are responsible for viewing full image series and making final clinical determinations.

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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### K242467 510(k) Summary-IQ UIP

### Submission Owner and Correspondent

Imbio, Inc. 1015 Glenwood Avenue Floor 4 Minneapolis, MN 55405 Contact: William McLain Phone: [phone] E-Mail: [e-mail]

Other submissions correspondents: Lauren Keith, Director of Engineering, [e-mail] and Kai Ludwig, Senior Imaging Scientist, [e-mail]

#### Date Summary Prepared

November 18, 2024

#### Device Trade Name

IQ-UIP

#### Device Common Name

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease

#### Device Classification Name

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease 21 CFR 892.2085 QWO

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### Legally Marketed Device To Which The Device Is Substantially Equivalent

The IQ-UIP Software is substantially equivalent to the Imvaria, Inc Fibresolve authorized under DEN220040.

### Description of the Device

lmbio IQ-UIP is a computer-aided software indicated for use in notifying specialists associated with Interstitial Lung Disease (ILD) Centers of radiological findings suggestive of radiological Usual Interstitial Pneumonia (UIP) in non-contrast, chest CT scans of adults.

Imbio IQ-UIP uses an artificial intelligence algorithm to analyze images and identify positive findings on a worklist application separate from and in parallel to the standard of care radiological image interpretation. Identification of positive findings include summary reports with a clinical guideline reference for the definition of UIP pattern that are meant for informational purposes only. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

The development of the deep learning inference model utilized anonymized, multi-center, retrospective, volumetric chest CT scans from several different, private and public data sources including multiple hospitals, clinical imaging centers, and imaging databases. Chest CT datasets were identified where each dataset represented an individual subject and acquisition. Data was subdivided into "bins" between the two stages of model development roughly 80%:20%: 1) model training and validation (i.e., hyper-parameter tuning) and 2) model testing (i.e. performance assessment). Site independence was maintained for several of the databases with clinical location data labels by randomly assigning each clinic location an integer value between 1 and 1000. Then, increasing from the lowest to highest random integer value, all data sets from a specific clinic location were assigned to the training bin until 80% of the total number of datasets from a database had been assigned to the training bin. The remaining were assigned to the testing bin. The testing data set was locked and quarantined from the datasets used in the device's model training and validation.

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The results of Imbio IQ-UIP are intended to be used in conjunction with other patient information and based on the user's professional judgment, to assist with the review of medical images. Notified clinicians are responsible for viewing full image series and making final clinical determinations.

### Indication for Use

Imbio IQ-UIP is a computer-aided software indicated for use in passively notifying specialists associated with interstitial lung disease (ILD) centers of radiological findings suggestive of radiological usual interstitial pneumonia (UIP) in non-contrast, chest CT scans of adults. Imbio IQ-UIP uses an artificial intelligence algorithm to analyze images and identify positive findings on a worklist application separate from and in parallel to the standard of care radiological image interpretation. Identification of positive findings include summary reports with a clinical guideline reference for the definition of UIP pattern that are meant for informational purposes only. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

The results of Imbio IQ-UIP are used to notify specialists at an ILD center of radiological findings that may be consistent with UIP. These specialists are qualified clinicians experienced in evaluating chest CTs for ILD. Input images originate from within the same hospital network associated with the ILD center. The results of Imbio IQ-UIP are intended to be used in conjunction with additional patient information and based on the user's professional judgment, to assist with the review of medical images. Notified clinicians are responsible for viewing full image series and making final clinical determinations.

### Technological Characteristics

The following table demonstrates the technical characteristics comparing the proposed to the predicate device.

| Characteristic | Predicate: Fibresolve<br>(DEN220040) | Proposed: IQ-UIP | Similarities or<br>Differences |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Clearance | DEN220040 | TBD | -- |
| Clearance Date | 01/12/2024 | TBD | -- |
| Product Code | QWO | QWO | Same |
| Characteristic | Predicate: Fibresolve<br>(DEN220040) | Proposed: IQ-UIP | Similarities or<br>Differences |
| Class | II | II | Same |
| Regulation | 892.2085 | 892.2085 | Same |
| Software | Device is software only | Device is software only | Same |
| Software<br>Documentation<br>Level | Moderate | Basic | Documentation is similar<br>and differences are due to<br>updated FDA guidance. |
| Indications for<br>Use | Fibresolve is a software-only device<br>that receives and analyzes lung<br>computed tomography (CT) imaging<br>data in order to provide a diagnostic<br>subtype classification in suspected<br>cases of interstitial lung disease<br>(ILD). The device supplements the<br>standard-of-care workflow by<br>providing a qualitative, diagnostic<br>classification output of imaging<br>findings based on machine learning<br>pattern recognition, in order to<br>provide adjunctive information as<br>part of a referral pathway to an<br>appropriate Multidisciplinary<br>Discussion (MDD) or as part of an<br>MDD. Specifically, the tool is used<br>to serve as an adjunct in the<br>diagnosis of idiopathic pulmonary<br>fibrosis (IPF) prior to invasive<br>testing. The results of Fibresolve are<br>intended to be used only by<br>clinicians qualified in the care of<br>lung disease, specifically in caring<br>for patients with ILD, in conjunction<br>with the patient's clinical history,<br>symptoms, and other diagnostic<br>tests, as well as the clinician's<br>professional judgment.<br>The input to Fibresolve is a DICOM-<br>compliant lung CT scan. Clinical<br>case eligibility includes the<br>following criteria:<br>Age > 22 years old.<br>Pulmonary symptoms suggestive of<br>possible ILD including IPF. | Imbio IQ-UIP is a computer-aided<br>software indicated for use in<br>passively notifying specialists<br>associated with interstitial lung<br>disease (ILD) centers of<br>radiological findings suggestive of<br>radiological usual interstitial<br>pneumonia (UIP) in non-contrast,<br>chest CT scans of adults. Imbio IQ-<br>UIP uses an artificial intelligence<br>algorithm to analyze images and<br>identify positive findings on a<br>worklist application separate from<br>and in parallel to the standard of<br>care radiological image<br>interpretation. Identification of<br>positive findings include summary<br>reports with a clinical guideline<br>reference for the definition of UIP<br>pattern that are meant for<br>informational purposes only. The<br>device does not alter the original<br>medical image and is not intended<br>to be used as a diagnostic device.<br>The results of Imbio IQ-UIP are<br>used to notify specialists at an ILD<br>center of radiological findings that<br>may be consistent with UIP. These<br>specialists are qualified clinicians<br>experienced in evaluating chest<br>CTs for ILD. Input images originate<br>from within the same hospital<br>network associated with the ILD<br>center. The results of Imbio IQ-UIP<br>are intended to be used in<br>conjunction with additional patient<br>information and based on the<br>user's professional judgment, to<br>assist with the review of medical | Similarities<br>• Referral software for<br>findings suggestive of<br>a pre-specified<br>clinical fibrotic lung<br>condition<br>• Uses artificial<br>intelligence to<br>analyze chest/lung CT<br>images<br>• Used by clinicians<br>qualified in the care<br>of lung disease<br>• Operates in parallel to<br>standard of care<br>workflow<br>• Provide qualitative<br>diagnostic subtype<br>classification for<br>cases suspected of<br>interstitial lung<br>disease<br>• Limited to analysis of<br>imaging data and<br>should not be used<br>in-lieu of full patient<br>evaluation or relied<br>upon to make or<br>confirm diagnosis |
| Characteristic | Predicate: Fibresolve<br>(DEN220040) | Proposed: IQ-UIP | Similarities or<br>Differences |
| | | images. Notified clinicians are<br>responsible for viewing full image<br>series and making final clinical<br>determinations. | Differences:<br>• IQ-UIP reports<br>viewable on<br>dedicated worklist<br>application separate<br>from standard-of-<br>care. |
| Technical<br>Method | The device supports referral of<br>findings related to fibrotic lung<br>diseases using machine learning,<br>artificial intelligence or other<br>image analysis algorithms. | The device supports referral of<br>findings related to fibrotic lung<br>diseases using machine<br>learning, artificial intelligence or<br>other image analysis algorithms. | Same |
| Target Area | The device operates on<br>radiological images of the<br>human body. | The device operates on<br>radiological images of the<br>human body. | Same |
| Anatomical Site | Lung/Chest | Lung/Chest | Same |
| Intended User<br>Population | Clinicians qualified in care of lung<br>disease | Clinicians qualified in care of lung<br>disease | Same |
| Patient<br>Population | Adults > 22 years old and with<br>pulmonary symptoms suggestive of<br>possible ILD including IPF. | Adults > 22 years old | Similarities:<br>• Adults > 22 years old<br><br>Differences:<br>• Fibresolve's patient<br>population is limited<br>to those adults with<br>pulmonary symptoms<br>suggestive of possible<br>ILD including IPF.<br>• IQ-UIP patient<br>population would<br>include the same<br>patient population as<br>those indicated for<br>Fibresolve but may<br>also include others<br>who have undergone a<br>chest CT for other<br>symptoms. |
| Communication<br>with Patient | Does not communicate images<br>to patients. | Does not communicate images<br>to patients. | Same |
| Characteristic | Predicate: Fibresolve<br>(DEN220040) | Proposed: IQ-UIP…