(61 days)
The Revolution™ 45 MHz Rotational IVUS Imaging Catheter is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
The Revolution™ 45 MHz Rotational IVUS Imaging Catheter consists of two main assemblies; the imaging core and the catheter body. The catheter body comprises three sections; the distal section with a 0.014" compatible F/X port, single lumen proximal section, and a telescope section. The distal section and proximal single lumen sections comprise the useable length of the catheter, the telescoping section remains outside of the guiding catheter. The telescope shaft allows the imaging core to be advanced and retracted for up to 150mm of linear movement. The corresponding movement of the transducer occurs from the proximal end of the guide wire exit port to the proximal end of the window portion of the distal section.
The imaging core is composed of a hi-torque, flexible, rotating drive cable with an outward looking 45MHz ultrasonic transducer at the distal tip. An electromechanical connector interface at the proximal end makes the connection to the patient-user interface (PIM) instrument. The PIM-catheter interface consists of an integrated mechanical drive assembly and electrical connection.
A flush port with a one-way valve is used to displace the air. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The one-way valve helps retain saline in the catheter during use.
The catheter body has a distal guidewire lumen with proximal exit port at 2cm from the distal end. A coupling is used to attach the catheter body to the telescope shaft. A radiopaque (RO) marker is embedded in the catheter body at 0.5cm from the tip. In addition, two insertion depth indicators are located on the catheter body at 90cm corresponding to brachial insertions, and at 100cm corresponding to femoral insertions.
The provided document describes a 510(k) submission for the Revolution™ 45 MHz Rotational IVUS Imaging Catheter, asserting its substantial equivalence to a predicate device. However, it does not contain detailed information regarding acceptance criteria for specific performance metrics, nor does it describe a study explicitly designed to prove the device meets such criteria in terms of diagnostic accuracy or clinical effectiveness.
The focus of this 510(k) summary is on demonstrating similarity in technological characteristics and intended use to a legally marketed predicate device, rather than providing new clinical performance data to establish entirely new safety and efficacy claims. It's a "Special 510(k)" indicating modifications to a previously cleared device.
Therefore, many of the requested sections regarding acceptance criteria and performance studies cannot be fully answered from the provided text.
Here is an attempt to address the points based on the available information:
1. Table of acceptance criteria and the reported device performance:
The document states: "Applicable testing was performed in accordance with Design Controls including a risk analysis addressing the impact of modifications to the device and components. The device was tested for biocompatibility according to ISO 10993-1 and the results met the predetermined acceptance criteria."
This is a very general statement about acceptance criteria for design control and biocompatibility, not specific performance metrics like diagnostic sensitivity, specificity, or image quality. No specific numerical acceptance criteria or reported performance values for diagnostic efficacy are provided.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Met ISO 10993-1 standards | Results met predetermined acceptance criteria. |
| Design Controls | In accordance with Design Controls and risk analysis addressing modifications | Performed |
| Substantial Equivalence | Same Intended Use and fundamental scientific technology as predicate device (Scout 3.2/45 MHz Coronary Imaging Catheter K974457) | Achieved (FDA concurred with substantial equivalence). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information about a specific "test set" for diagnostic performance is provided in this document. The submission relies on demonstrating substantial equivalence to a predicate device, not on new clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No ground truth establishment for a diagnostic test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set or adjudication method is described.
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:
Not applicable. This device is an Intravascular Ultrasound (IVUS) imaging catheter for direct visualization, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (imaging catheter), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no new diagnostic performance study requiring ground truth is described. The regulatory submission hinges on the established safety and efficacy of the predicate device.
8. The sample size for the training set:
Not applicable. This is a physical imaging catheter, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. (See #8)
§ 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).