(208 days)
The Direct Aortic Return Cannula is indicated for patients undergoing cardiopulmonary bypass. It is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The Direct Aortic Return Cannula also allows the hemostatic introduction and removal of vascular catheters such as the Heartport® Endoaortic Clamp™ catheter. The cannula may be introduced through a 12mm or larger trocar or incision.
The Cannula Introducer is intended for use with Heartport arterial return cannulae. It is intended for incising the vessel and introducing the cannula into the vessel.
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Here's a breakdown of the acceptance criteria and study information for the Heartport® Direct Aortic Return Cannula with Introducer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state specific quantifiable acceptance criteria such as "minimum flow rate of X mL/min" or "burst pressure of Y psi." Instead, it uses a more general statement.
| Acceptance Criteria Category | Acceptance Criteria (as stated in document) | Reported Device Performance (as stated in document) |
|---|---|---|
| Overall Performance | "meets established specifications" | "Performance testing demonstrated that the Heartport Direct Aortic Return Cannula with Introducer meets established specifications." |
| Biocompatibility | (Implied: safe for biological contact) | "The materials used in the Heartport Direct Aortic Return Cannula with Introducer have proven biocompatibility." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide information on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The "Non-Clinical Test Results" section is very brief and refers generally to "Performance testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the document describes a medical device (cannula and introducer) that is evaluated through non-clinical performance and biocompatibility testing, not through diagnostic accuracy studies requiring expert-established ground truth on a test set.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study is not applicable as this is a physical medical device, not an AI-assisted diagnostic tool where human reader performance would be assessed.
6. Standalone (Algorithm Only) Performance:
This information is not applicable as this is a physical medical device, not an algorithm or AI system.
7. Type of Ground Truth Used:
For a physical device like this, the "ground truth" for performance testing is typically defined by engineering specifications, material science standards, and accepted physiological parameters relevant to its intended use (e.g., flow rates, pressure resistance, material strength, sterility, biocompatibility). The document vaguely states "established specifications." For biocompatibility, the ground truth is established through in vitro and in vivo biocompatibility testing against recognized standards.
8. Sample Size for the Training Set:
This information is not applicable as this is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as this is a physical medical device, not a machine learning model that requires a training set with established ground truth. It is likely that the "specifications" for this device were established through engineering design, material selection, and existing industry standards for similar devices.
§ 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).