(7 days)
This product is intended for use with cardiopulmonary bypass as an arterial return cannula.
These cannulae are intended for use with cardiopulmonary bypass as an arterial return cannula.
The EOPA CAP™ Elongated One-Piece Arterial Cannula with Pressure Monitoring Line is designed for use with cardiopulmonary bypass as an arterial return cannula. The pressure monitoring line allows measurement of central arterial pressure. The device is available in 18, 20, 22, and 24 Fr. diameters, with vented or non-vented caps. The device may also include Carmeda® coating.
The provided text does not contain detailed acceptance criteria or a specific study that proves the device meets those criteria in the way typically expected for performance-based medical device submissions. This 510(k) summary is for a Class II vascular catheter and focuses on demonstrating substantial equivalence to predicate devices based on design, general functional testing, and indications for use, rather than a clinical performance study with defined quantitative acceptance metrics.
However, based on the information provided, here's a breakdown of what can be gleaned:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly present a table of quantitative acceptance criteria with corresponding performance data. The "Summary of Performance Data" describes the types of testing performed, implying that the device successfully met the requirements for those tests to demonstrate substantial equivalence.
| Acceptance Criteria Category (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Design Characteristics | Maintained same design characteristics as predicate devices. |
| Visual Inspection | Passed visual inspection. |
| Dimensional Specifications | Met dimensional specifications. |
| Simulated Use Testing | Performed adequately in simulated use. |
| Functional Testing | Performed adequately in functional tests, including pressure monitoring line functionality. |
| Bio-activity (for Carmeda® coated devices) | Passed bio-activity testing. |
| Coverage (for Carmeda® coated devices) | Passed coverage testing (of the coating). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The testing mentioned (visual, dimensional, simulated use, functional) implies a sample of devices were tested, but the exact number is not provided.
- Data Provenance: The type of testing (in vitro) suggests laboratory-based testing. The country of origin of the data is not explicitly stated but would presumably be where Medtronic Perfusion Systems conducted its internal testing. The data is retrospective in the sense that it was generated prior to the 510(k) submission for the purpose of demonstrating equivalence, not collected in an ongoing prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was an in vitro device performance evaluation, not a study requiring expert clinical assessment to establish ground truth. The "ground truth" would be established by validated test methods and measurement equipment.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical ground truth established by experts requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC comparative effectiveness study is not mentioned. This type of study is typically performed in areas like diagnostic imaging where different readers (e.g., radiologists) interpret cases with or without AI assistance, and their performance is compared. This device is an arterial cannula, which does not involve this type of interpretive task.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to a physical medical device like an arterial cannula. The "device" itself is a standalone product in the sense that it performs its intended function without requiring a human-in-the-loop interpretive component. The performance mentioned ("in vitro visual, dimensional, simulated use and functional testing") can be considered "standalone" device performance.
7. The Type of Ground Truth Used
The "ground truth" for this types of in vitro performance testing is typically defined by:
- Design Specifications: Meeting predefined dimensional, material, and functional specifications.
- Engineering Standards: Compliance with relevant engineering standards for performance (e.g., strength, flow rates).
- Predicate Device Performance Benchmarks: The device is expected to perform comparably to its legally marketed predicate devices, which serve as a benchmark for acceptable performance.
8. The Sample Size for the Training Set
Not applicable. The device is a physical medical device (an arterial cannula), not an algorithm or AI system that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of 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).