(263 days)
Not Found
Unknown
The description mentions "algorithm" for image analysis and comparison to expert manual analysis, which could potentially involve AI/ML, but it does not explicitly state or describe the use of AI/ML techniques.
No
This device is for post-processing analysis of OCT images and quantification of dimensions, which is a diagnostic tool, not a therapeutic one.
No
The device is described as a "post-processing analysis device used for viewing and quantifying intravascular OCT images." It is used to "review and analyze Intravascular optical coherence tomography (OCT) images" and "enables quantification of artery and/or stent dimensions." While it processes medical images and provides measurements, its described function is analysis and quantification of existing images, not the direct diagnosis of a medical condition. A diagnostic device would typically be directly involved in identifying or determining the presence or nature of a disease or condition. This device aids in the interpretation of diagnostic images, but it is not performing the diagnosis itself.
Yes
The device is described as a "web-accessible post-processing analysis device" that "visualize[s] and quantif[ies] OCT pullback data in raw OCT file format." It is a "web-based platform" used in "common desktop web browsers." The description focuses entirely on the software's functionality for image analysis, quantification, and reporting, and there is no mention of any accompanying hardware component being part of the device itself. It processes data from a separate, compatible imaging system (Abbott Laboratories C7-XR system).
Based on the provided information, the Libby IAAA device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue, etc.) to provide information for diagnostic purposes.
- Libby IAAA analyzes medical images: The Libby IAAA device is specifically designed to review and analyze intravascular optical coherence tomography (OCT) images. These are medical images obtained from within the body, not biological samples taken from the body.
The device's function is image processing and analysis for the purpose of quantifying anatomical structures and dimensions within the artery based on OCT images. This falls under the category of medical image analysis software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Libby IAAA is intended to review and analyze Intravascular optical coherence tomography (OCT) images in raw OCT file format. IAAA enables quantification of artery and/or stent dimensions. The software is intended to be used by or under supervision of a Cardiologist.
Product codes
LLZ
Device Description
The Libby IAAA v1.0 platform is a web-accessible post-processing analysis device used for viewing and quantifying intravascular OCT images. The device is intended to visualize and quantify OCT pullback data in raw OCT file format. The device enables lumen, stent, and stent strut detection and has features for loading, saving, and report generation of aggregated quantitative data. The device allows for analysis of raw Intravascular optical coherence tomography (OCT) files obtained from the Abbott Laboratories C7-XR system and compatible imaging catheters.
The web-based platform can be used in common desktop web browsers. A user opens an intravascular image pullback file using the platform and has the ability to use various modules to perform image analysis on areas of interest. The platform includes the following module panels for visualization, quantification, and report generation:
Visualization:
- 2D cross-sectional view
- 2D longitudinal view
- Image navigation tools
- Measurement and annotation tools
- Bookmark areas of interest
Quantification:
- Distance and area measurements
- Guidewire detection
- Lumen and Stent area quantification
- Stent and strut detection (pullback level and frame level)
- Strut classification (covered versus uncovered, apposed, and malapposed)
Data Reporting:
Study information, lumen areas, stent areas, reference areas, percent stenosis, along with user-created annotations are displayed to the user within the software automatically saves all data and the user has the option to generate a report in .xlsx format.
The product is intended to be used by or under supervision of a board-certified Cardiologist.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intravascular optical coherence tomography (OCT) images
Anatomical Site
artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by or under supervision of a Cardiologist. Healthcare facilities such as hospitals and clinics.
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
Standalone performance testing consisted of a head to head analysis of a generalized dataset manually analyzed by expert cardiologists and compared to the performance of the Libby IAAA algorithm.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety and performance of the Libby IAAA v1.0 has been evaluated and verified in accordance with software specifications, applicable performance standards through software verification and validation testing, and a standalone performance test. Standalone performance testing consisted of a head to head analysis of a generalized dataset manually analyzed by expert cardiologists and compared to the performance of the Libby IAAA algorithm. The software system testing activities were performed in accordance with ANSI/AAMI/IEC 62304:2006/A1:2016 - Medical device software - Software life cycle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices. "
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 17, 2021
Dyad Medical, Inc. Rory Carrillo Quality & Regulatory 215 Brighton Avenue, Suite 203 Boston, Massachusetts 02134
Re: K210931
Trade/Device Name: Libby IAAA v1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: November 12, 2021 Received: November 18, 2021
Dear Rory Carrillo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210931
Device Name Libby IAAA v1.0
Indications for Use (Describe)
Libby IAAA is intended to review and analyze Intravascular optical coherence tomography (OCT) images in raw OCT file format. IAAA enables quantification of artery and/or stent dimensions. The software is intended to be used by or under supervision of a Cardiologist.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for DYAD Medical. The logo consists of a blue graphic on the left and the text "DYAD MEDICAL" on the right. The graphic is a stylized representation of connected circles or ovals, with a gradient from light to dark blue. The text "DYAD" is in a larger, bold font, while "MEDICAL" is in a smaller font below it.
510(k) Summary
1. General Information
| 510(k) Sponsor | Dyad Medical, Inc. |
|---|---|
| Address | 215 Brighton Avenue, Suite 203 |
| Boston, MA 02134 | |
| Correspondence Person | Rory A. Carrillo |
| Quality and Regulatory Consultant | |
| RAC Medical Consulting, LLC | |
| Contact Information | Email: rory@cosmhq.com |
| Phone: 562-533-7010 | |
| Date Prepared | March 29, 2021 |
2. Proposed Device
| Proprietary Name | Libby IAAA v1.0 |
|---|---|
| Premarket Notification | K210931 |
| Common Name | Libby IAAA |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Regulation Name | Picture archiving and communication system |
| Product Code | LLZ |
| Regulatory Class | II |
3. Predicate Device
| Proprietary Name | Pie Medical CAAS Intravascular |
|---|---|
| Premarket Notification | K123970 |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Regulation Name | Picture archiving and communications system |
| Product Code | LLZ |
| Regulatory Class | II |
Device Description 4.
The Libby IAAA v1.0 platform is a web-accessible post-processing analysis device used for viewing and quantifying intravascular OCT images. The device is intended to visualize and quantify OCT pullback data in raw OCT file format. The device enables lumen, stent, and stent strut detection and has features for loading, saving, and report generation of aggregated
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Image /page/4/Picture/1 description: The image contains the logo for DYAD MEDICAL. The logo consists of a blue graphic on the left and the text "DYAD MEDICAL" on the right. The graphic is a stylized representation of connected circles or spheres, with a gradient of blue shades. The text "DYAD" is in a larger, bolder font, while "MEDICAL" is in a smaller font below it.
quantitative data. The device allows for analysis of raw Intravascular optical coherence tomography (OCT) files obtained from the Abbott Laboratories C7-XR system and compatible imaging catheters.
The web-based platform can be used in common desktop web browsers. A user opens an intravascular image pullback file using the platform and has the ability to use various modules to perform image analysis on areas of interest. The platform includes the following module panels for visualization, quantification, and report generation:
Visualization:
- 2D cross-sectional view
- 2D longitudinal view ●
- Image navigation tools
- Measurement and annotation tools ●
- Bookmark areas of interest ●
Quantification:
- Distance and area measurements ●
- Guidewire detection
- Lumen and Stent area quantification ●
- Stent and strut detection (pullback level and frame level) ●
- Strut classification (covered versus uncovered, apposed, and malapposed) ●
Data Reporting:
Study information, lumen areas, stent areas, reference areas, percent stenosis, along with usercreated annotations are displayed to the user within the software automatically saves all data and the user has the option to generate a report in .xlsx format.
The product is intended to be used by or under supervision of a board-certified Cardiologist.
ನ. Intended Use
Libby IAAA is intended to review and analyze Intravascular optical coherence tomography (OCT) images in raw OCT file format. IAAA enables quantification of artery and/or stent dimensions. The software is intended to be used by or under supervision of a Cardiologist.
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Image /page/5/Picture/0 description: The image contains the logo for DYAD Medical. On the left side of the logo is a blue graphic that looks like three cells connected together. To the right of the graphic is the text "DYAD MEDICAL" with "DYAD" on top of "MEDICAL".
6. Substantial Equivalence
| Feature/
Function | Proposed Device:
Libby IAAA v1.0
(K210931) | Predicate Device:
Pie Medical CAAS Intravascular
(K123970) |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use
& Indications
for Use | Libby IAAA is intended to review
analyze
optical
and
coherence
tomography
(OCT)
images in raw OCT file format.
IAAA enables quantification of
artery and/or stent dimensions. The
software is intended to be used by or
under supervision of a Cardiologist. | CAAS IntraVascular has been
developed to review and analyze
intravascular images. The software is
used by or under supervision of a
cardiologist or radiologist.
Based on intravascular ultrasound
(IVUS) and/or optical coherence
tomography (OCT) images CAAS
IntraVascular enables quantification
of artery and/or stent dimensions. |
| Intended Users | The software is used by or under
supervision of a Cardiologist. | The software is used by or under
supervision of a cardiologist or
radiologist. |
| Intended
Environment | Healthcare facilities such as
hospitals and clinics | Healthcare facilities such as hospitals
and clinics |
| Device Class | II | II |
| Data Type | Raw OCT data | IVUS and OCT data in DICOM
format (vendor independent) |
| Import of
Patient Data | -Manual through keyboard
-Automatic import with image file
-Study List creation | -Manual through keyboard
-Automatic import with image file
-Study List creation |
| Image Display | - 2D OCT reconstruction
- Cross-sectional views
- Longitudinal reconstruction | -3D OCT reconstruction
- Cross-sectional views
- Longitudinal reconstruction |
| Contour
Definition | Lumen and stent contour
-Automatic
-Manual | Lumen, EEM and stent contour
-Automatic
-Manual |
| Vessel Analysis | - Stenosis analysis - Stent analysis | - Stenosis analysis
- Plaque analysis
- Stent analysis |
| | | |
| Image
Assessment | - Linear (length and diameter),
angular and ROI measurements - Volume measurements | - Linear (length and diameter),
angular and ROI measurements - Volume measurements |
| Storage of
Results | - Digital report (.xlsx) | -Printout
-Reanalysis
-Digital PDF report
-XML export
-DICOM PDF report |
| Operating
System | Web Browser | MS Windows |
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Image /page/6/Picture/0 description: The image contains the logo for DYAD MEDICAL. On the left side of the logo, there is a blue graphic that looks like three cells connected together. On the right side of the logo, the words DYAD MEDICAL are written in bold, blue letters.
7. Performance Data
Safety and performance of the Libby IAAA v1.0 has been evaluated and verified in accordance with software specifications, applicable performance standards through software verification and validation testing, and a standalone performance test. Standalone performance testing consisted of a head to head analysis of a generalized dataset manually analyzed by expert cardiologists and compared to the performance of the Libby IAAA algorithm. The software system testing activities were performed in accordance with ANSI/AAMI/IEC 62304:2006/A1:2016 - Medical device software - Software life cvcle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices. "
8. Conclusion
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, the Libby IAAA v1.0 raises no different questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, effectiveness, and performance.