Elucid PlaqueIQ

K241524 · Elucid Bioimaging, Inc. · LLZ · Sep 12, 2024 · Radiology

Device Facts

• Record ID: K241524
• Device Name: Elucid PlaqueIQ
• Applicant: Elucid Bioimaging, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Elucid PlaquelQ is intended to support qualified clinicians in the non-invasive evaluation and assessment of plaque quantification and morphology (e.g., atherosclerosis) from previously acquired CT angiography. The results are intended to support qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.

Device Story

Elucid PlaqueIQ is a cloud-based image analysis application for evaluating CT angiography images of arterial vessels. Unlike on-premise predicate devices where physicians perform segmentations, Elucid PlaqueIQ utilizes Elucid Analysts to generate segmentations as a service. The device processes CT data to provide multi-dimensional visualization, plaque quantification, and morphology assessment. Clinicians access the resulting graphics and text via an internet-connected device. The output serves as a supplemental diagnostic aid; clinicians review the analysis and may request rework if necessary. By providing standardized, repeatable plaque quantification, the device assists physicians in clinical decision-making regarding atherosclerosis management.

Clinical Evidence

Bench testing only. Evidence includes software verification testing for functionality and repeatability, validation testing against pre-defined acceptance criteria, and usability testing with intended users. No clinical trial data was required or presented.

Technological Characteristics

Cloud-based image analysis software; DICOM compatible. Provides 2D (MPR, curved MPR, straightened view) and 3D visualization, MIP, and MPR with oblique slicing. Operates on Windows and Mac OS. Software-only device; no patient contact. Verification and validation confirm performance specifications.

Indications for Use

Indicated for qualified clinicians to evaluate and assess plaque quantification and morphology (e.g., atherosclerosis) in patients using previously acquired CT angiography images. Prescription use only.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Autoplaque add-on ORS Visual (K122429)

Reference Devices

• vascuCAP A.1.2 (K183012)

Submission Summary (Full Text)

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September 12, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of a human figure, while the right side features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Elucid Bioimaging, Inc. Hiral Vora Lead Quality and Regulatory Affairs Specialist 399 Bovlston Street Suite 400 Boston, MA 02116

Re: K241524

Trade/Device Name: Elucid PlaqueIQ Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: August 5, 2024 Received: August 5, 2024

Dear Hiral Vora:

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 (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.

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,

Samul for

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

510(k) Number (if known) K241524

Device Name Elucid PlaqueIO

#### Indications for Use (Describe)

Elucid PlaquelQ is intended to support qualified clinicians in the non-invasive evaluation and assessment of plaque quantification and morphology (e.g., atherosclerosis) from previously acquired CT angiography. The results are intended to support qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.

Prescription use only.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

# K241524

## Submitter Information

| Submitter / Manufacturer Name | Elucid Bioimaging, Inc.<br>399 Boylston Street, Suite 400, Boston, MA 02116 |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Primary Correspondent &<br>Contact Information | Hiral Vora<br>Lead Quality and Regulatory Affairs Specialist<br>Email ID: [e-mail] |
| Secondary Correspondent &<br>Contact Information | Windi Hary<br>SVP, Quality and Regulatory<br>Email ID: [e-mail] |
| Date Prepared | 11 September 2024 |

## Device Identification

| Proprietary Name: | Elucid PlaquelQ |
|-----------------------------|------------------------------------------------|
| Device Classification Name: | System, Image Processing, Radiological |
| Regulation Description: | Medical image management and processing system |
| Regulation Number: | 892.2050 |
| Device Class | Class II |
| Product Code: | LLZ |

## Predicates

| Proprietary Name: | Autoplaque add-on ORS Visual |
|-----------------------------|------------------------------------------------|
| Device Classification Name: | System, Image Processing, Radiological |
| Regulation Description: | Medical image management and processing system |
| 510(k) Number: | K122429 |
| Regulation Number: | 892.2050 |
| Device Class | Class II |
| Product Code: | LLZ |

### Reference Device

| Proprietary Name: | vascuCAP A.1.2 |
|-----------------------------|-----------------------------------------|
| Device Classification Name: | "System, Image Processing, Radiological |

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| Regulation Description: | Medical image management and processing system |
|-------------------------|------------------------------------------------|
| 510(k) Number: | K183012 |
| Regulation Number: | 892.2050 |
| Device Class | Class II |
| Product Code: | LLZ |

#### Device Description

Elucid PlaquelQ is an image analysis application for evaluating CT angiography images of arterial vessels. Elucid PlaquelQ provides multi-dimensional visualization to aid clinicians in their analysis of plaque anatomy and pathology (e.g., atherosclerosis). Elucid PlaquelQ supports physician review and interrogation of the Elucid conducted segmentation to inform their clinical interpretation of the Elucid PlaqueIQ Analysis.

#### Indications of Use

Elucid PlaquelQ is intended to support qualified clinicians in the non-invasive evaluation and assessment of plaque quantification and morphology (e.g., atherosclerosis) from previously acquired CT angiography. The results are intended to support qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.

Prescription use only.

#### Indications of Use comparison discussion

Autoplaque is an on-prem desktop plaque analysis application, where physicians generate segmentations and apply plaque algorithms for quantification. The results are then presented to the physician. Elucid PlaquelO is a cloud-based application, where Elucid Analysts generate the segmentations (as a service) and apply plaque algorithms for quantification. The results are then provided to the physician. Elucid monitors their analyst/product performance to ensure repeatability and reproducibility of the segmentations and plaque outputs. Therefore, we feel the differences in indications do not present any additional concerns of safety or effectiveness.

#### Technological Characteristic Comparison

Elucid PlaquelQ is an image analysis software that is used to process, review, and analyze CT images. lt has the same technological characteristics as the predicate device. It does not comtact with the patient, nor does it control any life-sustaining devices. It provides physicians with a tool that aids with interpretation of CT images and information displayed. Even though there are some technological differences between subject device and predicate device in terms of computer operating system, and provision of product as stand-alone device; these differences do not impact the safety and effectiveness of the product. Additionally, these differences are addressed through software verification and validation.

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#### Predicate Device Comparison

| Comparison Criteria | Elucid PlaqueIQ (B.1P)<br>(Subject Device) | Autoplaque add-on<br>ORS Visual (Primary<br>Predicate) | vascuCAP A.1.2<br>(Reference Device) | Comparison<br>Assessment |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| 510(k) | To be assigned | K1224291 | K183012 | |
| Manufacturer | Elucid Bioimaging, Inc. | Object Research<br>Systems (ORS) inc. | Elucid Bioimaging, Inc. | |
| Product Code | LLZ | LLZ | LLZ | Same as predicate |
| Regulation Number | 892.2050 | 892.2050 | 892.2050 | Same as predicate |
| Regulation Description | Medical image<br>management and<br>processing system | Medical image<br>management and<br>processing system | Medical image<br>management and<br>processing system | Same as predicate |
| Device Classification Name | System, Image<br>Processing,<br>Radiological | System, Image<br>Processing,<br>Radiological | System, Image<br>Processing,<br>Radiological | Same as predicate |
| Device Class | Class II | Class II | Class II | Same as predicate |
| Data Source (input) | CT | CT | CT | Same as predicate |
| Output | Graphics and text<br>results of arterial<br>anatomy that can be<br>accessed by end<br>users/physicians using<br>a device with internet<br>connectivity | Graphic and text<br>results of coronary<br>anatomy that can be<br>accessed by end<br>users/physicians using<br>the product. | Graphics and text<br>results of arterial<br>anatomy that can be<br>accessed by end<br>users/physicians using<br>a device with internet<br>connectivity | Similar to predicate |
| Physical Characteristics | Cloud-based<br>segmentation and<br>analysis as service<br>- DICOM<br>compatible | Software<br>installed and used by<br>end-user<br>- DICOM<br>compatible | Software<br>installed and used by<br>end-user<br>- DICOM<br>compatible | Similar to predicate |
| Safety | Clinician review and<br>assessment of analysis<br>prior to use as | Clinician editable,<br>review, and<br>assessment of analysis | Clinician editable,<br>review and assessment<br>of analysis prior to use | Similar to predicate<br>except clinicians<br>cannot edit the |
| | supplemental<br>diagnostic aid | prior to use as<br>supplemental<br>diagnostic aid | as supplemental<br>diagnostic aid | analysis; however,<br>they can request<br>rework of the<br>analysis. |
| Computer Operating System | Windows OS and Mac<br>OS | Windows OS | Windows OS and Mac<br>OS | Similar to predicate<br>except subject device<br>can be operated on<br>Mac OS system as<br>well |
| 2D Imaging | Review of arterial<br>vessels in 2D MPR,<br>curved MPR, and<br>straightened view. | Review of coronary<br>vessels in 2D MPR,<br>curved MPR, and<br>straightened view. | Review of arterial<br>vessels in 2D MPR,<br>curved MPR, and<br>straightened view. | Similar to predicate |
| 3D Imaging | Review of structures in<br>3D | Review of structures in<br>3D | Review of structures in<br>3D | Same as predicate |
| Maximum intensity projection<br>(MIP) | MIP with interactive<br>control | MIP with interactive<br>control | MIP with interactive<br>control | Same as predicate |
| Multiplanar reformatting<br>(MPR) | MPR with oblique<br>slicing and variable<br>slab thickness | MPR with oblique<br>slicing and variable<br>slab thickness | MPR with oblique<br>slicing and variable<br>slab thickness | Same as predicate |

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# Summary of Tests

The software was designed, developed, verified and validated for performance per the written procedures. Verification, validation and usability testing data demonstrated that the device meets all of its specifications demonstrating substantial equivalence to the predicate device.

Any risks identified during product development were controlled and mitigated by a risk management plan including risk analysis, risk evaluation, risk control and evaluation of residual risks.

The following non-clinical tests were performed:

- 1. Verification testing verified the overall functionality and repeatability conforming to the software specifications.
- 2. Validation testing confirmed that the performance of the software met the pre-defined acceptance criteria.
- 3. Usability testing was conducted with intended users of the device and ensures the acceptability of the device.

The nonclinical verification and validation test results established that the device meets its design requirements and intended use.

#### Conclusion

Based on the intended use, technological characteristic, summary of tests and comparison to the predicate, Elucid PlaquelQ raises no new questions of safety and effectiveness as compared to the predicate and is substantially equivalent to the predicate device in terms of safety, efficacy, and performance.