(127 days)
DualView Catheter is intended for the intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.
The DualView Catheter is a catheter consisting of two assemblies: the catheter sheath and the imaging core (consisting of lens and transducer). During imaging, the imaging core rotates inside the catheter sheath to obtain a 360°image of the surface layer of the vessel wall by irradiating with near-infrared light and ultrasound. By pulling back the imaging core inside the catheter sheath, an image in the long axis direction can be obtained.
This is a rapid exchange (RX) design (short monorail) catheter, which is used with a 0.014" (0.36 mm) guidewire. The catheter is 2.6 Fr (0.86 mm) in the imaging window section and 3.0 Fr (1.01 mm) in the shaft section with an effective length of 137 cm. The catheter has a 100 cm hydrophilic coating starting from the distal end, which becomes highly lubricious when wet. The catheter has a telescoping section, and the telescoping length is 155 mm. When connected to the OPUSWAVE, the imaging core can be pulled back 150 mm in the catheter sheath. There are two radiopaque markers. The distal radiopaque marker is located 7 mm from the distal end of the catheter sheath, and the sensor radiopaque marker is located where the near-infrared light and ultrasound are emitted. Those markers allow a user to confirm the positional relationship between the distal end of the catheter and the sensor position (imaging point). There are two depth markers, one at 90 cm and the other at 100 cm from the distal end of the catheter sheath, which serves as a guide for insertion.
The transducer has an IPX7 ingress rating in accordance with IEC 60529.
The catheter is stored in the holder tube and is secured to the catheter holder. The catheter comes with the Motor Drive Unit (MDU) Cover and accessories. The MDU Cover consists of an adapter and a plastic cover sheet to maintain the sterility of the catheter and clean field. The catheter accessories consist of a connection tube with a three-way stopcock, a priming syringe, and a reservoir syringe for priming the catheter lumen with heparinized saline solution.
The provided FDA 510(k) Clearance Letter concerns the DualView Catheter, a diagnostic intravascular catheter. This document is a Summary of a Traditional 510(k) submission, which primarily focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance testing.
Therefore, the submission does not include a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, standalone algorithm performance, or extensive details on ground truth establishment involving human expert consensus for a clinical test set as would be typical for an AI/ML-based device. The clearance is based on direct device performance and safety, primarily through bench testing and animal studies, not a human reader study.
Here's an analysis of the provided information, specifically addressing the questions as much as possible given the nature of this particular 510(k) (a medical device clearance, not an AI/ML algorithm clearance):
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):
Since this is a non-clinical device clearance, the "acceptance criteria" are the successful completion of the listed performance and safety tests, demonstrating the device meets its design specifications and is suitable for its intended use. The "reported device performance" is that it successfully met these criteria.
| Acceptance Criteria (Test Item) | Reported Device Performance |
|---|---|
| Radio-detectability | Met requirements |
| Appearance of Catheter | Met requirements |
| Corrosion Resistance | Met requirements |
| Tensile Strength | Met requirements |
| Freedom from leakage | Met requirements |
| Small bore connector | Met requirements |
| Sliding resistance (Imaging window) | Met requirements |
| Particle count | Met requirements |
| Slidability of Guidewire | Met requirements |
| Bending strength | Met requirements |
| Dimensions | Met requirements |
| Imaging quality | Met requirements |
| Pullback/forward durability | Met requirements |
| Coating Integrity | Met requirements |
| Stent crossability | Met requirements |
| Simulated use – Human factor usability engineering | Met requirements |
| Software Verification and Validation | Conducted per IEC 62304 and FDA guidance ("Enhanced" level) - Met requirements |
| Electrical Safety & EMC | Compliant with IEC 60601-1, -2-18, -1-2, -2-37, and IEC 60825 - Met requirements |
| Biocompatibility | Compliant with ISO 10993-1, tested on accelerated aged devices - Met requirements |
| Sterilization | Validated per ISO 11135:2014/Amd 1:2018 (SAL of 10-6) - Met requirements |
| Animal Study (Safety) | No issues related to tissue damage and thrombus formation in coronary arteries |
| Animal Study (Performance) | System performed as intended compared to predicate devices |
Detailed Study Information (Where Applicable for this Device Type):
-
Sample sizes used for the test set and the data provenance:
- Test Set (Non-Clinical): The document refers to various non-clinical tests (e.g., performance testing, software V&V, electrical safety, biocompatibility, sterilization). The "sample size" for these tests would correspond to the number of catheters or test articles subjected to each specific test. This specific number is not provided in the summary but is assumed to be sufficient for each test type according to relevant standards.
- Animal Study: A "swine model" was used for both safety and performance animal studies. The specific number of animals is not provided in this summary.
- Data Provenance: The document does not explicitly state the country of origin for the data (e.g., test labs, animal facilities). This is a traditional 510(k) submission, and the manufacturer is Terumo Corporation (Japan), with manufacturing in Japan. Animal studies were likely prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in the context of this 510(k). This clearance is for a medical device (catheter), not an AI/ML algorithm that requires human expert consensus for image interpretation ground truth. The "ground truth" for this device's performance is established by direct physical measurements, engineering validations, and physiological outcomes in animal models against predefined specifications and safety standards.
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Adjudication method for the test set:
- Not Applicable. Since there's no human interpretation component needing adjudication for ground truth establishment. Test outcomes are determined by objective measurements against acceptance criteria.
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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, an MRMC study was NOT done. The document explicitly states: "This 510(k) does not include data from clinical tests." MRMC studies are typically used to assess the impact of AI algorithms on human reader performance, which is not relevant for this device's non-clinical clearance pathway.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, not in the sense of an AI algorithm. This device does not appear to involve an AI algorithm whose performance would be assessed in a standalone manner for image interpretation or diagnosis. It is a diagnostic imaging catheter that generates images for human interpretation.
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The type of ground truth used:
- Engineering Specifications, Physical Measurements, and Physiological Outcomes (Animal Model):
- For non-clinical performance tests (e.g., tensile strength, dimensions, imaging quality, etc.), the ground truth is the device's adherence to pre-defined engineering specifications and measurable performance characteristics.
- For biocompatibility and sterilization, the ground truth is established by adherence to relevant ISO standards and successful completion of validated tests.
- For animal studies, the "ground truth" relates to the physiological effects observed (e.g., absence of tissue injury, thrombus formation) and the successful performance of the device in a living system as intended by design, compared to predicate devices.
- Engineering Specifications, Physical Measurements, and Physiological Outcomes (Animal Model):
-
The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a training set of data.
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How the ground truth for the training set was established:
- Not Applicable. As no training set for an AI/ML algorithm is involved.
Summary:
The DualView Catheter received 510(k) clearance based on demonstrating substantial equivalence to predicate devices primarily through rigorous non-clinical performance testing and animal studies. This type of submission relies on showing that the new device meets established safety and performance standards equivalent to existing legally marketed devices, rather than a clinical study evaluating an AI algorithm's interpretive accuracy and its impact on human readers. Therefore, many of the questions pertinent to AI/ML device clearances (e.g., human expert ground truth, MRMC studies) are not applicable to this traditional medical device submission.
§ 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).