The Dragonfly OpStar™ Imaging Catheter with the OCT imaging system is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragong Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OpStar 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.

Device Description

The Dragonfly OpStar Imaging Catheter is a sterile, single-use intravascular catheter consisting of a catheter body external sheath and an internal rotating fiber optic imaging core. The external sheath serves two primary functions: 1) to facilitate placement of the device into the coronary artery and 2) to cover and protect the internal rotating fiber optic imaging core. The inner rotating fiber optic imaging core emits near infrared light to tissues and receives reflected light. It is driven by a stainless-steel torque wire visible under fluoroscopy and pulled back through the window tube of the external sheath by the Drive-motor and Optical Controller (DOC). The emitted and returned reflected light are combined and processed by the OPTIS System software to construct an Optical Coherence Tomography (OCT) image. The patient is never exposed to moving parts as the external sheath completely covers the rotating imaging core.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dragonfly OpStar™ Imaging Catheter.

Important Note: The provided document is an FDA 510(k) clearance letter and summary. It focuses on demonstrating substantial equivalence to a predicate device, not on detailed clinical or standalone performance studies against specific acceptance criteria for a novel AI/software component. The "device" in this context refers to the physical imaging catheter, not an AI or software algorithm that provides diagnostic interpretations. Therefore, many of the requested items (like AI performance, ground truth establishment, expert adjudication, MRMC studies) are not applicable or not present in this type of submission.

Let's break down what information is available and what is not for the "device" (the catheter itself).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria and reported performance for the Dragonfly OpStar™ Imaging Catheter in the way one would for an AI diagnostic algorithm. Instead, it relies on demonstrating substantial equivalence to a predicate device (K192019). The "performance" assessment is qualitative, focusing on meeting design specifications and not raising new safety or effectiveness concerns.

Acceptance Criteria Category (Derived from generally expected device performance)	Reported Device Performance (from document)
Intended Use Equivalence: The device's intended use must be similar to the predicate.	The Dragonfly OpStar™ Imaging Catheter with the OCT imaging system is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The document explicitly states: "The Dragonfly OpStar Imaging Catheter is substantially equivalent to the predicate Dragonfly OpStar Imaging Catheter (K192019) in terms of intended use..."
Indications for Use Equivalence: The device's indications for use must be similar to the predicate.	Indicators for use include: "imaging of coronary arteries," "candidates for transluminal interventional procedures," "vessels 2.0 to 3.5 mm in diameter." Exclusions: "not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure." The document states: "...substantially equivalent to the predicate Dragonfly OpStar Imaging Catheter (K192019) in terms of...indications for use..." It also explicitly compares and lists "Same" for the predicate device's indications for use.
Operational Characteristics Equivalence: The device's operational characteristics must be similar to the predicate.	The device is described as "a sterile, single-use intravascular catheter consisting of a catheter body external sheath and an internal rotating fiber optic imaging core." Its mechanism of action (emits near infrared light, receives reflected light, processed by OPTIS System software) is identical to the predicate. The document states: "...substantially equivalent to the predicate Dragonfly OpStar Imaging Catheter (K192019) in terms of...operational characteristics..."
Fundamental Design Equivalence: The device's fundamental design must be similar to the predicate.	The description of the device's components and function matches the predicate. The document states: "...substantially equivalent to the predicate Dragonfly OpStar Imaging Catheter (K192019) in terms of...fundamental design..."
Technological Characteristics Equivalence: The device's technological characteristics must be similar to the predicate.	The document explicitly states: "There are no technological differences between the predicate device and new device." It also reiterates: "...substantially equivalent to the predicate Dragonfly OpStar Imaging Catheter (K192019) in terms of...technological characteristics."
Safety and Effectiveness: Demonstrate the device is safe and effective for its intended use and does not raise new safety/effectiveness issues.	"Design verification and validation bench tests were performed... The results demonstrate that the Dragonfly OpStar Imaging Catheter meets the user needs and product specifications and is appropriate for its intended use and does not raise any new issues of safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of a diagnostic test set. The testing performed was "Design verification and validation bench tests." These typically involve testing individual catheter units, components, and system functionalities.
Data Provenance: Not applicable in the context of clinical data for a diagnostic algorithm. The tests were "bench tests," meaning they were conducted in a laboratory or simulated environment, not on human patients or derived from patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable to this submission. The device is an imaging catheter that produces images, not an AI algorithm that interprets them to make a diagnosis requiring expert ground truth for validation. The "ground truth" for bench testing would be engineering specifications and measurements (e.g., catheter diameter, image resolution, material strength).

4. Adjudication Method for the Test Set

This is not applicable. Since there's no diagnostic interpretation requiring expert consensus, no adjudication method was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing is provided in this pre-market notification." This type of study would be relevant for evaluating AI-assisted interpretation, which is not the subject of this 510(k) (it's for the physical catheter).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. This question is relevant for AI algorithms. The device's "performance" described relates to its physical and functional capabilities as an imaging tool, not its interpretive accuracy.

7. The Type of Ground Truth Used

The ground truth for the "Design verification and validation bench tests" would be engineering specifications and measurements. For example, if a test was to verify the catheter's diameter, the ground truth would be the specified diameter in the design documents, and the test would confirm that measured catheters fall within acceptable tolerances of that specification.

8. The Sample Size for the Training Set

This information is not applicable. This question is for AI/machine learning algorithms. The Dragonfly OpStar™ Imaging Catheter is a physical medical device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As above, this pertains to AI/machine learning training, which is not described for this device.

Summary

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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 14, 2023

Abbott Medical Mingzi Deng Associate Director, Regulatory Affairs 4 Robbins Road Westford, Massachusetts 01886

Re: K230411

Trade/Device Name: Dragonfly OpStar™ Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DOO Dated: February 14, 2023 Received: February 15, 2023

Dear Mingzi Deng:

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

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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 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 (QS) 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 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-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 S. Deoras -S

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

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Indications for Use

510(k) Number (if known) K230411

Device Name Dragonfly OpStar™ Imaging Catheter

Indications for Use (Describe)

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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510(K) SUMMARY

510(k) SUMMARY
	510(k) SummaryPer 21 CFR §807.92
510(k) Number	K230411
Date Prepared	February 14, 2023
Submitter Name& Address	Abbott Medical4 Robbins RoadWestford, MA, 01886
Contact Person	Derek Pike978-577-3595
AlternativeContact Person	Mingzi Deng781-640-4474
Proprietary /Trade Name	Dragonfly OpStarTM Imaging Catheter
Common / UsualName	Diagnostic Imaging Catheter
ProductClassification	Product Code: DQO
ProductRegulationNumber	21 CFR 870.1200
Predicate Device	Dragonfly OpStarTM Imaging Catheter, AptiVueTM Software version E.5.1(K192019), cleared 11 November 2019
DeviceDescription	The Dragonfly OpStar Imaging Catheter is a sterile, single-use intravascularcatheter consisting of a catheter body external sheath and an internal rotatingfiber optic imaging core. The external sheath serves two primary functions: 1) tofacilitate placement of the device into the coronary artery and 2) to cover andprotect the internal rotating fiber optic imaging core. The inner rotating fiberoptic imaging core emits near infrared light to tissues and receives reflected light.It is driven by a stainless-steel torque wire visible under fluoroscopy and pulledback through the window tube of the external sheath by the Drive-motor andOptical Controller (DOC). The emitted and returned reflected light are combinedand processed by the OPTIS System software to construct an Optical CoherenceTomography (OCT) image. The patient is never exposed to moving parts as theexternal sheath completely covers the rotating imaging core.
Indications forUse / IntendedUse	The Dragonfly OpStarTM Imaging Catheter with the OCT imaging system isintended for the imaging of coronary arteries and is indicated in patients who arecandidates for transluminal interventional procedures. The Dragonfly OpStarImaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. TheDragonfly OpStar Imaging Catheter is not intended for use in the left maincoronary artery or in a target vessel which has undergone a previous bypassprocedure.

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Comparison ofSubject toPredicate Device	The Dragonfly OpStar Imaging Catheter is substantially equivalent to the predicate Dragonfly OpStar Imaging Catheter (K192019) in terms of intended use, indications for use, operational characteristics, fundamental design, and technological characteristics. There are no technological differences between the predicate device and new device.
		Feature	Predicate Device:Dragonfly OpStar ImagingCatheter (K192019)
	Intended Use	The Dragonfly OpStarImaging Catheter with theOCT imaging system isintended for the visualizationand imaging of coronaryarteries during aninterventional procedure.	Same
	Indicationsfor Use	Intended for the imaging ofcoronary arteries and isindicated in patients who arecandidates for transluminalinterventional procedures.The Dragonfly OpStarImaging Catheter is intendedfor use in vessels 2.0 to 3.5mm in diameter. TheDragonfly OpStar ImagingCatheter is not intended foruse in the left main coronaryartery or in a target vesselwhich has undergone aprevious bypass procedure.	Same
Summary onNon-ClinicalTesting	Design verification and validation bench tests were performed on the DragonflyOpStar Imaging Catheter in compliance with internal design control procedures.The results demonstrate that the Dragonfly OpStar Imaging Catheter meets theuser needs and product specifications and is appropriate for its intended use anddoes not raise any new issues of safety and effectiveness.
Summary ofClinical Testing	No clinical testing is provided in this pre-market notification.
Statement ofEquivalence	The Dragonfly OpStar Imaging Catheter is substantially equivalent to thepredicate Dragonfly OpStar Imaging Catheter (K192019) in terms of intendeduse, indications for use, operational characteristics, fundamental design, andtechnological characteristics.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).