(46 days)
The CentriMag Return (Arterial) Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
The Thoratec CentriMag Return (Arterial) Cannula Kit consists of the return (arterial) cannula and several accessories used in the surgical placement procedure. The cannula and all kit accessories are sterile, single-use, disposable devices. The cannula kit is designed for use with the Thoratec CentriMag® Extracorporeal Blood Pumping System (K020271).
The Cannula Kit includes the following accessories:
| QTY | Kit Component |
|---|---|
| 1 | Return (Arterial) Cannula Body |
| 1 | Connector, 3/8-inch, barbed |
| 1 | Introducer |
| 1 | Hemostasis Seal |
| 1 | Cap (with Umbilical tape) |
| 1 | Porous Plug |
| 1 | Guidewire Assembly |
| 1 | Introducer Needle |
| 4 | Suture Rings (small) |
| 4 | Suture Rings (medium) |
| 4 | Tip Rings |
This document describes a 510(k) premarket notification for the "Thoratec CentriMag Return (Arterial) Cannula Kit." This is a medical device and not an AI/ML algorithm, so many of the requested fields are not applicable. I will provide information relevant to device testing as presented in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Flex Test | Device integrity maintained | Successful results |
| Tensile Strength Test | Device integrity maintained under tensile stress | Successful results |
| Chemical Resistance Test | Device integrity maintained after exposure to chemicals | Successful results |
| Pressure Test | Device integrity maintained under pressure | Successful results |
| Suture and Tip Ring Security and Deformation Test | Rings remain secure and do not deform beyond acceptable limits | Successful results |
| Dimensional Verification Examination | Dimensions meet specifications | Successful results |
| Cannula Body Material Examination | Material properties meet specifications | Successful results |
| Material Evaluation (Chemical Characterization) | New materials are chemically suitable | Successful results |
| Biocompatibility | New materials are biocompatible | Successful results |
| Microbiological Performance (Reduced Confirmatory Revalidation) | Device maintains sterility | Successful results |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for each performance test. It only mentions that "All testing employed devices that were exposed to 2x sterilized, accelerated-aging to simulate a real-time equivalent of 1-year, and heated saline soak for 30 days."
Data Provenance: Not specified, but generally, device performance testing data comes from the manufacturer's internal testing labs. It is a prospective study in the sense that the tests were designed and executed to evaluate the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is evaluated through engineering and biocompatibility testing, not expert interpretation of outputs.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI/ML algorithm or a diagnostic test requiring human adjudication. Device performance is determined by meeting physical and chemical specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This is a medical device, not an AI/ML diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm. The performance tests are inherently "standalone" in that they assess the device itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance testing is based on:
- Engineering specifications and design requirements (e.g., specific tensile strength values, pressure limits, dimensional tolerances).
- Material science standards (e.g., chemical composition analysis, biocompatibility standards).
- Sterility standards (microbiological performance).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device undergoing performance and material testing, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device.
§ 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).