(106 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on image analysis and visualization without mentioning AI/ML techniques.
No
The device is an image analysis application intended for the evaluation and assessment of plaque quantification and morphology from previously acquired CT angiography images. Its purpose is to support clinicians in diagnosis and analysis, not to directly treat or prevent a disease or condition.
Yes
Explanation: The device is intended for the "non-invasive evaluation and assessment of plaque quantification and morphology," and its results are meant to "support qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests," which directly points to a diagnostic purpose.
Yes
The device is described as an "image analysis application" and its function is to process previously acquired CT angiography images. There is no mention of any accompanying hardware or physical components that are part of the device itself. The description focuses solely on the software's capabilities for visualization and analysis.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: Elucid PlaquelQ analyzes previously acquired CT angiography images. This is an imaging modality, not a test performed on a biological sample.
- Intended Use: The intended use is to support clinicians in evaluating and assessing plaque from these images. This is an image analysis tool, not a diagnostic test performed on a biological specimen.
The device processes medical images to provide information to clinicians, which falls under the category of medical image analysis software, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT angiography
Anatomical Site
arterial vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified clinicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 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:
-
- Verification testing verified the overall functionality and repeatability conforming to the software specifications.
-
- Validation testing confirmed that the performance of the software met the pre-defined acceptance criteria.
-
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
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"
1
(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
2
assistance/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,
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
3
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary
K241524
Submitter Information
| Submitter / Manufacturer Name | Elucid Bioimaging, Inc.
399 Boylston Street, Suite 400, Boston, MA 02116 |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Primary Correspondent &
Contact Information | Hiral Vora
Lead Quality and Regulatory Affairs Specialist
Email ID: hiral.vora@elucid.com |
| Secondary Correspondent &
Contact Information | Windi Hary
SVP, Quality and Regulatory
Email ID: windi.hary@elucid.com |
| 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 |
5
| 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.
6
Predicate Device Comparison
| Comparison Criteria | Elucid PlaqueIQ (B.1P)
(Subject Device) | Autoplaque add-on
ORS Visual (Primary
Predicate) | vascuCAP A.1.2
(Reference Device) | Comparison
Assessment |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| 510(k) | To be assigned | K1224291 | K183012 | |
| Manufacturer | Elucid Bioimaging, Inc. | Object Research
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
management and
processing system | Medical image
management and
processing system | Medical image
management and
processing system | Same as predicate |
| Device Classification Name | System, Image
Processing,
Radiological | System, Image
Processing,
Radiological | System, Image
Processing,
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
results of arterial
anatomy that can be
accessed by end
users/physicians using
a device with internet
connectivity | Graphic and text
results of coronary
anatomy that can be
accessed by end
users/physicians using
the product. | Graphics and text
results of arterial
anatomy that can be
accessed by end
users/physicians using
a device with internet
connectivity | Similar to predicate |
| Physical Characteristics | Cloud-based
segmentation and
analysis as service
- DICOM
compatible | Software
installed and used by
end-user - DICOM
compatible | Software
installed and used by
end-user - DICOM
compatible | Similar to predicate |
| Safety | Clinician review and
assessment of analysis
prior to use as | Clinician editable,
review, and
assessment of analysis | Clinician editable,
review and assessment
of analysis prior to use | Similar to predicate
except clinicians
cannot edit the |
| | supplemental
diagnostic aid | prior to use as
supplemental
diagnostic aid | as supplemental
diagnostic aid | analysis; however,
they can request
rework of the
analysis. |
| Computer Operating System | Windows OS and Mac
OS | Windows OS | Windows OS and Mac
OS | Similar to predicate
except subject device
can be operated on
Mac OS system as
well |
| 2D Imaging | Review of arterial
vessels in 2D MPR,
curved MPR, and
straightened view. | Review of coronary
vessels in 2D MPR,
curved MPR, and
straightened view. | Review of arterial
vessels in 2D MPR,
curved MPR, and
straightened view. | Similar to predicate |
| 3D Imaging | Review of structures in
3D | Review of structures in
3D | Review of structures in
3D | Same as predicate |
| Maximum intensity projection
(MIP) | MIP with interactive
control | MIP with interactive
control | MIP with interactive
control | Same as predicate |
| Multiplanar reformatting
(MPR) | MPR with oblique
slicing and variable
slab thickness | MPR with oblique
slicing and variable
slab thickness | MPR with oblique
slicing and variable
slab thickness | Same as predicate |
7
8
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:
-
- Verification testing verified the overall functionality and repeatability conforming to the software specifications.
-
- Validation testing confirmed that the performance of the software met the pre-defined acceptance criteria.
-
- 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.