(58 days)
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.
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.
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.
§ 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).