Libby IAAA v1.0

K210931 · Dyad Medical, Inc. · LLZ · Dec 17, 2021 · Radiology

Device Facts

• Record ID: K210931
• Device Name: Libby IAAA v1.0
• Applicant: Dyad Medical, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 17, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

Libby IAAA v1.0 is a web-based post-processing platform for intravascular OCT images. Input consists of raw OCT pullback files from Abbott C7-XR systems. The device provides visualization (2D cross-sectional/longitudinal views) and automated/manual quantification tools. Key functions include lumen, stent, and stent strut detection; strut classification (covered/uncovered, apposed/malapposed); and distance/area measurements. Used in hospitals/clinics by cardiologists or supervised staff. Output includes quantitative data, annotated images, and .xlsx reports. The device assists clinicians in assessing vessel/stent status, supporting clinical decision-making regarding coronary interventions.

Clinical Evidence

Bench testing only. Performance evaluated via software verification and validation per ANSI/AAMI/IEC 62304. Standalone performance testing conducted using a generalized dataset; Libby IAAA algorithm performance compared against manual analysis by expert cardiologists.

Technological Characteristics

Web-based software platform; compatible with standard desktop web browsers. Performs automated and manual lumen, stent, and strut detection/quantification. Software life cycle processes follow ANSI/AAMI/IEC 62304:2006/A1:2016. Cybersecurity controls implemented per FDA guidance.

Indications for Use

Indicated for use by or under the supervision of a cardiologist to review and analyze intravascular optical coherence tomography (OCT) images in raw file format for the quantification of artery and/or stent dimensions.

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

• Pie Medical CAAS Intravascular (K123970)

Submission Summary (Full Text)

{0}------------------------------------------------

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 ([e-mail]) or phone [phone] 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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<br>Boston, MA 02134 |
| Correspondence Person | Rory A. Carrillo<br>Quality and Regulatory Consultant<br>RAC Medical Consulting, LLC |
| Contact Information | Email: [e-mail]<br>Phone: [phone] |
| 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

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains the words "Traditional 510(k)". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Traditional" on the left and "510(k)" on the right. The text is black against a white background.

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.

{5}------------------------------------------------

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/<br>Function | Proposed Device:<br>Libby IAAA v1.0<br>(K210931) | Predicate Device:<br>Pie Medical CAAS Intravascular<br>(K123970) |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use<br>& Indications<br>for Use | Libby IAAA is intended to review<br>analyze<br>optical<br>and<br>coherence<br>tomography<br>(OCT)<br>images in raw OCT file format.<br>IAAA enables quantification of<br>artery and/or stent dimensions. The<br>software is intended to be used by or<br>under supervision of a Cardiologist. | CAAS IntraVascular has been<br>developed to review and analyze<br>intravascular images. The software is<br>used by or under supervision of a<br>cardiologist or radiologist.<br>Based on intravascular ultrasound<br>(IVUS) and/or optical coherence<br>tomography (OCT) images CAAS<br>IntraVascular enables quantification<br>of artery and/or stent dimensions. |
| Intended Users | The software is used by or under<br>supervision of a Cardiologist. | The software is used by or under<br>supervision of a cardiologist or<br>radiologist. |
| Intended<br>Environment | Healthcare facilities such as<br>hospitals and clinics | Healthcare facilities such as hospitals<br>and clinics |
| Device Class | II | II |
| Data Type | Raw OCT data | IVUS and OCT data in DICOM<br>format (vendor independent) |
| Import of<br>Patient Data | -Manual through keyboard<br>-Automatic import with image file<br>-Study List creation | -Manual through keyboard<br>-Automatic import with image file<br>-Study List creation |
| Image Display | - 2D OCT reconstruction<br>- Cross-sectional views<br>- Longitudinal reconstruction | -3D OCT reconstruction<br>- Cross-sectional views<br>- Longitudinal reconstruction |
| Contour<br>Definition | Lumen and stent contour<br>-Automatic<br>-Manual | Lumen, EEM and stent contour<br>-Automatic<br>-Manual |
| Vessel Analysis | - Stenosis analysis<br>- Stent analysis | - Stenosis analysis<br>- Plaque analysis<br>- Stent analysis |
| | | |
| Image<br>Assessment | - Linear (length and diameter),<br>angular and ROI measurements<br>- Volume measurements | - Linear (length and diameter),<br>angular and ROI measurements<br>- Volume measurements |
| Storage of<br>Results | - Digital report (.xlsx) | -Printout<br>-Reanalysis<br>-Digital PDF report<br>-XML export<br>-DICOM PDF report |
| Operating<br>System | Web Browser | MS Windows |

{6}------------------------------------------------

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.