Cornaris Intravascular Imaging System with Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. LumenCross Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The LumenCross Imaging Catheter (referred to as LumenCross) with the Cornaris Intravascular Imaging System produced by Vivolight, which is intended for intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for transluminal interventional procedures. The LumenCross intended for use in vessels 2.0~3.5mm in diameter. The LumenCross is not indicated for use in the left main coronary artery or in a target vessel that has undergone a previous bypass procedure.

Device Description

Cornaris Intravascular Imaging System are cart-mounted computer and Imaging Engin(or optical engine) placed inside an ergonomically designed mobile cart with the cable underground. There are two models, P80-E is mainly composed of trolley, mouse, keyboard, two display monitors, optical engine, computer. Mobile-E is mainly composed of trolley, mouse, keyboard, one display monitor, monitor bracket, optical engine, computer. The both also includes the catheter connection unit (PIU), which provides the interconnection between the Cornaris Intravascular Imaging System and the LumenCross Imaging Catheter.P80-E and Mobile-E has the same software features.

The imaging catheter contains two main components: the catheter body and imaging core (internal rotating fiber optic). The outer diameter of the distal shaft of the catheter was 2.67 F (0.89 mm, 0.035 in.), and the length of the distal shaft was 280mm. The imaging catheter has a working length of 1350mm. The imaging catheter is compatible with 0.014" (0.356 mm) guidewire, which with a guidewire lumen length of 16 mm, the guidewire enters through tip entrance and exit through the RX port. The hydrophilic coating is applied on the outer surface of distal shaft. The LumenCross Imaging Catheter is a single use device. The LumenCross Imaging Catheter is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of two years.

AI/ML Overview

The provided FDA 510(k) clearance letter and its summary do not contain detailed information regarding the acceptance criteria, nor the specific study design and results typically associated with proving a device meets those criteria, especially in terms of algorithm performance for an imaging system. The submission focuses more on general product specifications, non-clinical bench testing, and animal studies related to the physical and material performance of the imaging catheter and system, rather than the quantitative performance of any imaging interpretation algorithm or AI component.

However, based on the information provided, we can infer some aspects and highlight what is missing for a complete answer to your request.

Here's a breakdown based on the provided text, with explicit notes where information is missing:

Overview of Device and Purpose

The Cornaris Intravascular Imaging System (P80-E, Mobile-E) and LumenCross Imaging Catheter (F2) are intended for imaging coronary arteries during transluminal interventional procedures. The system utilizes Optical Coherence Tomography (OCT) to visualize vessel structures. The 510(k) submission focuses on demonstrating substantial equivalence to predicate devices (ILUMIEN OPTIS and DRAGONFLY OPTIS IMAGING CATHETER).

1. Table of Acceptance Criteria and Reported Device Performance

The submission describes various performance tests conducted. These are primarily for hardware, optical parameters, and catheter physical characteristics, rather than interpretive accuracy.

Acceptance Criterion (Measured Parameter)	Reported Device Performance (or Compliance Statement)	Notes on Relevance to AI/Imaging Interpretation
Cornaris Intravascular Imaging System:
Scan range	(Compliance implied by substantial equivalence)	Ensures adequate imaging area.
Axial resolution	(Compliance implied by substantial equivalence)	Affects image quality and detail.
Luminous Sensitivity	(Compliance implied by substantial equivalence)	Affects image quality and signal strength.
A-line speed	(Compliance implied by substantial equivalence)	Affects imaging speed.
Dynamic range	(Compliance implied by substantial equivalence)	Affects image contrast and detail.
Frame rate	(Compliance implied by substantial equivalence)	Affects imaging speed.
Pullback time and range	(Compliance implied by substantial equivalence)	Relates to image acquisition protocol.
Fiber Optic Rotary Joint (FORJ) Insertion loss	(Compliance implied by substantial equivalence)	Ensures proper optical signal transmission.
Fiber Optic Rotary Joint (FORJ) Rotational homogeneity	(Compliance implied by substantial equivalence)	Ensures consistent imaging across the rotation.
Fiber Optic Rotary Joint (FORJ) Return loss	(Compliance implied by substantial equivalence)	Ensures proper optical signal transmission.
LumenCross Imaging Catheter:
Visual & Dimensional Inspection	(Compliance implied by substantial equivalence)	Basic quality control.
Catheter bond Strength	(Compliance implied by substantial equivalence)	Safety and durability.
Simulated use	(Compliance implied by substantial equivalence)	Evaluates real-world performance.
Leakage	(Compliance implied by substantial equivalence)	Safety.
Corrosion	(Compliance implied by substantial equivalence)	Safety and durability.
Torque	(Compliance implied by substantial equivalence)	Ease of use and maneuverability in vessel.
Particulates	(Compliance implied by substantial equivalence)	Safety (embolism risk).
Coating integrity	(Compliance implied by substantial equivalence)	Safety and ease of use.
Flexibility and Kink	(Compliance implied by substantial equivalence)	Ease of use and safety (prevents damage).
Endotoxin	(Compliance implied by substantial equivalence)	Safety (prevents systemic reactions).
Biological Safety Testing (LumenCross):
Cytotoxicity	(Compliance met per ISO 10993-1)	Biocompatibility.
Sensitization	(Compliance met per ISO 10993-1)	Biocompatibility.
Mouse Lymphoma Assay	(Compliance met per ISO 10993-1)	Biocompatibility (genotoxicity).
Bacterial Reverse Mutation Assay	(Compliance met per ISO 10993-1)	Biocompatibility (mutagenicity).
Intracutaneous Reactivity	(Compliance met per ISO 10993-1)	Biocompatibility.
Acute Systemc Toxicity	(Compliance met per ISO 10993-1)	Biocompatibility.
Material Mediated Pyrogenicity	(Compliance met per ISO 10993-1)	Biocompatibility.
Hemolysis (Direct and Indirect)	(Compliance met per ISO 10993-1)	Biocompatibility.
Complement SC5b-9	(Compliance met per ISO 10993-1)	Biocompatibility.
In Vivo Thrombogenicity	(Compliance met per ISO 10993-1)	Biocompatibility.
Pre-clinical testing (Animal Study):
Clear Image Length (CIL)	"no significant differences between the subject device and the predicate device"	Directly relates to imaging performance.
Device Performance (system stability, ease of operation, usability of sterile cover and PIU, catheter crossability, catheter vulnerability, catheter marker visualization)	"no significant differences between the subject device and the predicate device"	Relates to practical usability and image quality.
In vivo thrombus formation	"no significant differences between the subject device and the predicate device"	Safety.
Safety	"no significant differences between the subject device and the predicate device"	Overall safety.

Crucially, this submission does not describe acceptance criteria or performance for an AI algorithm's interpretation of images. It focuses on the hardware's ability to produce images and the catheter's physical characteristics. If there were an AI component for image analysis (e.g., automated lumen segmentation, plaque characterization), specific performance metrics (e.g., accuracy, sensitivity, specificity, Dice score for segmentation) would be listed here, along with their acceptance thresholds. This information is not present in the provided document.

Specific Study Details (as inferable from the document, with noted gaps):

Since the document focuses on showing substantial equivalence through non-clinical and pre-clinical tests, and explicitly states "No clinical study is included in this submission," most of the questions about AI algorithm performance studies cannot be answered from this text.

2. Sample size used for the test set and the data provenance:
* Test Set Sample Size: Not specified for a data-driven algorithm test set. The pre-clinical animal study "conducted to support substantial equivalence" did involve a "test set" of animal cases, but the exact number of animals or images generated from that study is not provided.
* Data Provenance: The animal study is an in vivo (likely prospective) study, but the country of origin is not specified. It's safe to assume it was conducted under the company's control, likely in China given their location.
* Retrospective/Prospective: The biological and pre-clinical studies were prospective tests on either ex-vivo materials or in-vivo animal models.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not Applicable / Not Specified: The ground truth for the biological and physical properties was established by adherence to ISO standards and direct measurements. For the animal study performance metrics, "no significant differences" were found, implying comparison to a predicate device or expert assessment, but the number or qualifications of experts involved in this specific assessment are not detailed. An AI study would typically involve expert readers.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not Applicable / Not Specified: For the physical and biological tests, adjudication methods are not relevant. For the animal study, it's not specified how the "no significant differences" conclusion was reached, or if formal adjudication was used for subjective performance measures like "ease of operation."

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* No MRMC Study: The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study comparing human readers with and without AI assistance was performed or reported here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not Indicated: The submission does not describe any standalone algorithm performance testing. This suggests that the device, as cleared, does not include an AI algorithm that performs any automated image analysis or diagnosis requiring such testing. The "Software Features for Imaging" mentioned seem to refer to basic imaging display and system control, not AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Defined Standards/Measurements & Comparative Animal Study:
* For the physical and biological tests, ground truth was implicitly defined by the relevant ISO standards (e.g., ISO 10993-1) and direct physical measurements.
* For the pre-clinical animal study, the "ground truth" was the observed performance of the device and its direct comparison to a predicate device (e.g., "Clear Image Length (CIL)" and "in vivo thrombus formation"). This is an in-vivo assessment.

8. The sample size for the training set:
* Not Applicable / Not Specified: Since no AI algorithm training is described, there is no mention of a training set.

9. How the ground truth for the training set was established:
* Not Applicable / Not Specified: As no AI training data is mentioned, the method for establishing its ground truth is also not.

Conclusion:

The provided FDA 510(k) summary focuses on demonstrating the substantial equivalence of the Cornaris Intravascular Imaging System and LumenCross Imaging Catheter to existing predicate devices based on physical, mechanical, optical, biological, and pre-clinical animal performance. It does not present any information related to the performance of an artificial intelligence (AI) component for image interpretation or analysis. Therefore, it cannot address the questions concerning acceptance criteria and study details for an AI algorithm's performance. The "device performance" described pertains to the system's ability to acquire and display images, and the catheter's physical safety and functionality, rather than any automated interpretive function.

Summary

FDA 510(k) Clearance Letter - K242098

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

April 11, 2025

Shenzhen Vivolight Medical Device & Technology Co., Ltd.
Gao Pengyang
RA Manager & Regulatory Affairs Department
Room 511-A, 5th Floor, Block B, Building R2,
High-Tech Industrial Park, No. 020
South Seventh Road Gaoxin Community
Shenzhen, Guangdong 518055
China

Re: K242098
Trade/Device Name: Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)
Regulation Number: 21 CFR 892.1560
Regulation Name: Ultrasonic Pulsed Echo Imaging System
Regulatory Class: Class II
Product Code: NQQ, DQO
Dated: March 14, 2025
Received: March 14, 2025

Dear Gao Pengyang:

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

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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" (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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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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-devices/device-advice-comprehensive-regulatory-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,

MARCO CANNELLA -S

for

Aneesh Deoras
Assistant Director
DHT2A: Division of Cardiac
Electrophysiology, Diagnostics, and
Monitoring Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K242098

Device Name
Cornaris Intravascular Imaging System (P80-E);
Cornaris Intravascular Imaging System (Mobile-E);
LumenCross Imaging Catheter (F2)

Indications for Use (Describe)

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)

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.

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510(k)#: K242098

510(k) Summary

Prepared on: 2025-04-09

Contact Details

21 CFR 807.92(a)(1)

Applicant Name	Shenzhen Vivolight Medical Device & Technology Co., Ltd.
Applicant Address	Room 511-A, 5th Floor, Block B, Building R2, High-Tech Industrial Park, No. 020, South Seventh Road Gaoxin Community, Yuehai Street, Nanshan District Shenzhen Guangdong 518055 China
Applicant Contact Telephone	86 755 86961139
Applicant Contact	Mr. Gao Pengyang
Applicant Contact Email	gaopengyang@vivo-light.com

Device Name

21 CFR 807.92(a)(2)

Device Trade Name	Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)
Common Name	Ultrasonic pulsed echo imaging system
Classification Name	System, Imaging, Optical Coherence Tomography (Oct)
Regulation Number	892.1560, 870.1200
Product Code(s)	NQQ, DQO

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K150878	ILUMIEN OPTIS	NQQ
K141453	DRAGONFLY OPTIS IMAGING CATHETER	DQO
K152120	OPTIS Mobile System	NQQ
K230411	Dragonfly OpStar Imaging Catheter	DQO

Device Description Summary

21 CFR 807.92(a)(4)

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is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of two years.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Indications for Use Comparison

21 CFR 807.92(a)(5)

The indication of Cornaris fall within the indications of the predicate device. The Predicate device has the FFR function, lack of this function have no impact on Imaging function of OCT equipment and does not raise a new intended use. LumenCross has the same intended use with the predicate device.

Technological Comparison

21 CFR 807.92(a)(6)

The Cornaris is same to the ILUMIEN OPTIS in the following ways:

Same Mode of Operation for Imaging;
Same System components;
Same Optical Parameters for Imaging;
Same Image Display;
Same Software Features for Imaging.

and also have the different Characteristics in the following ways:

Different Dimensions and Weight
Different Visible Laser Parameters
Different Pullback length and speed

LumenCross Imaging Catheter is same to the DRAGONFLY OPTIS IMAGING CATHETER in the following ways:

Same Outer Diameter
Same Working length
Same Compatible guide catheter
Same Compatible Guidewire
Same number of Radiopaque marker
Same Purge
Same Sterile and single use

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

Performance testing was conducted against known standards or the product specification and evaluated the following:

Cornaris Intravascular Imaging System

Scan range
Axial resolution
Luminous Sensitivity
A-line speed
Dynamic range
Frame rate
Pullback time and range
Fiber Optic Rotary Joint (FORJ) Insertion loss
Fiber Optic Rotary Joint (FORJ) Rotational homogeneity
Fiber Optic Rotary Joint (FORJ) Return loss.

LumenCross Imaging Catheter

Visual & Dimensional Inspection
Catheter bond Strength
Simulated use

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Leakage
Corrosion
Torque
Particulates
Coating integrity
Flexibility and Kink
Endotoxin

Biological Safety Testing

The LumenCross was subjected to a series of biocompatibility tests in accordance with FDA guidance, using International Standard ISO 10993-1.

Cytotoxicity
Sensitization
Mouse Lymphoma Assay
Bacterial Reverse Mutation Assay
Intracutaneous Reactivity
Acute Systemic Toxicity
Material Mediated Pyrogenicity
Hemolysis (Direct and Indirect)
Complement SC5b-9
In Vivo Thrombogenicity

Pre-clinical testing

Animal study was conducted to support substantial equivalence. The criteria included Clear Image Length (CIL), Device Performance (system stability, ease of operation, usability of the sterile cover and PIU, catheter crossability, catheter vulnerability, catheter marker visualization), in vivo thrombus formation, and safety. The results demonstrated no significant differences between the subject device and the predicate device.

No clinical study is included in this submission.

The nonclinical tests and pre-clinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the predicate device.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.