(30 days)
The Spherical Tip Coronary Ostial Cannula is intended for use in conjunction with cardiopulmonary bypass surgery up to six hours or less, for delivery of cardioplegia solutions directly to the coronary arteries.
The Spherical Coronary Artery Ostial Cannula is a line extension of existing Meditonic The Sphorour Soronary Artery Ostial Cannulae and features a uniquely shaped spherical tip. This product is used for the delivery of antegrade cardioplegia solution through the coronary artery ostia during cardiac bypass surgery. The Spherical Coronary Artery Ostial Cannula is intended as an addition to the current line of hand-held cardioplegia perfusion cannulae. Prior products included flanged basket and conforming silicone tips as a means to seal against the ostial opening and deliver cardioplegia. The distal end of the cannula features a dual-diameter, spherical bulb tip rather than a flanged basket tip for interface to the ostial opening. The released models feature a basket tip with a ring flange that is pressed up against the ostial opening by the physician during cardioplegia delivery. Delivery using the proposed design would, similarly, require the spherical bulb to be pressed against the ostial opening while solution is dispensed through the smaller tip extension.
The provided document does not contain acceptance criteria or a detailed studyproving the device meets acceptance criteria. Instead, it is a 510(k) summary for a medical device (Spherical Tip Coronary Ostial Cannula) seeking substantial equivalence to a predicate device.
The summary focuses on:
- Device Description: Highlighting a unique spherical tip as a line extension to existing models.
- Indication for Use: Stating the device's purpose in delivering cardioplegia solutions during cardiac bypass surgery.
- Comparison to Predicate Device: Emphasizing that the primary difference is the tip configuration, while indications for use are the same.
- Summary of Performance Data: Briefly mentioning that "In vitro and functional testing was completed on the modified product to ensure that the product integrity and function is maintained."
- Conclusion: Asserting substantial equivalence based on design and indications for use.
Therefore, I cannot fill in the table or answer the specific questions regarding acceptance criteria, sample sizes, ground truth, experts, or MRMC studies because this information is not present in the provided text.
The document states that "In vitro and functional testing was completed" to ensure product integrity and function, but it does not provide:
- Specific acceptance criteria for this testing.
- Details of the test methodology.
- The results of the testing (e.g., reported device performance).
- Any information regarding sample sizes, data provenance, ground truth establishment, or human-in-the-loop studies.
§ 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).