(20 days)
The Steerable Coronary Sinus Catheter is indicated for occlusion of the coronary sinus, delivery of cardioplegic solution, and monitoring of coronary sinus pressure during cardiopulmonary bypass.
The Steerable Coronary sinus Catheter is a 9 Fr., three-lumen catheter in the distal balloon. The three lumen are used to inflate the balloon (to occlude the coronary sinus), monitor coronary sinus pressure and for delivery of cardioplegia solution.
The provided text describes a 510(k) premarket notification for a medical device, the CardioVations Steerable Coronary Sinus Catheter. However, it does not contain detailed information about specific acceptance criteria or the results of a formal study proving the device meets those criteria, as one would typically expect for an AI/ML device or a device requiring extensive performance testing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Results of verification testing indicates that the product meets the established performance requirements."
This is a very general statement and does not provide specific acceptance criteria or quantitative performance measures. Therefore, a table cannot be constructed with detailed information.
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Meets established performance requirements | Product meets the established performance requirements. |
| Functions as intended | The modified device has the same technological characteristics as the predicate device. The form, fit, function and method of operation are similar. |
| Safety and Effectiveness | Device is substantially equivalent to legally marketed predicate devices, implying similar safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the document. The text only mentions "verification testing" without specifying the sample size, type of data (e.g., in vitro, animal, human), or provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided. Given the nature of the device (a catheter), the "ground truth" would likely relate to its physical performance, material properties, and ergonomic aspects, rather than expert interpretation of medical images or data. No mention of expert consensus for performance evaluation is made.
4. Adjudication Method for the Test Set:
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not provided. An MRMC study is typically relevant for diagnostic devices where human readers interpret output, often with AI assistance. This device is a catheter for surgical procedures, so an MRMC study is highly unlikely for this type of product.
6. Standalone (Algorithm Only) Performance Study:
This information is not provided. This device is a physical medical instrument, not an AI algorithm, so a "standalone algorithm only" performance study is not applicable.
7. Type of Ground Truth Used:
The document implies that the ground truth for evaluating the device would be based on its physical and functional performance against established engineering specifications and its comparison to a predicate device. It's not explicitly stated, but for a catheter, this would typically involve:
- Physical measurements (e.g., diameter, length, lumen size).
- Material testing (e.g., biocompatibility, tensile strength, kink resistance).
- Functional testing (e.g., balloon inflation, fluid delivery rates, steerability).
- Performance in simulated environments or animal models to assess occlusion, cardioplegia delivery, and pressure monitoring.
The concept of "expert consensus," "pathology," or "outcomes data" as ground truth is not directly applicable in the typical sense for this device.
8. Sample Size for the Training Set:
This information is not provided. The device is a physical product, not an AI/ML model, so the concept of a "training set" in the context of machine learning is not applicable here.
9. How the Ground Truth for the Training Set was Established:
This information is not provided, as the concept of a training set is not applicable to this type of device.
In summary: The provided document is a 510(k) summary for a medical device that predates the modern era of AI/ML devices. Therefore, it focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and unspecified "verification testing" results, rather than detailed performance studies against specific acceptance criteria using AI-centric methodologies. The information requested regarding sample sizes, ground truth establishment for training/test sets, expert involvement, and MRMC studies is not present because these concepts are generally not relevant to the evaluation of a physical, non-AI medical instrument described in this submission.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).