(29 days)
The DLP Aortic Root Cannula (Model 23009) is intended for short term use (six hours or less) in conjunction with cardiopulmonary bypass surgery for delivering cardioplegia solutions. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. The Model 23009 cannula may also be used to monitor pressure in the aorta.
The DLP Aortic Root Cannula with Vent Line (Model 24009) is intended for use during cardiopulmonary bypass for delivering cardioplegia solutions and venting of the left heart for up to 6 hours. The cannula may be used to aspirate air from the aorta at the conclusion of the bypass procedure. The Model 24009 cannula may also be used to monitor pressure in the aorta.
The DLP Cardioplegia Adapter with Pressure Port (Model 15004) is intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure monitoring for up to 6 hours.
The DLP Pressure Monitoring Extension Line Adapter (Models 25009 and 25010) is intended for extending the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery up to 6 hours or less.
The proposed modification will affect the DLP Aortic Root Cannula with Integral Pressure Monitoring Line and Extension Set product family. A description of these devices follows below.
Model 23009: The DLP Aortic Root Cannula consists of flexible tubing permanently attached to both the inlet and tip. The inlet fitting is a female luer fitting. The introducer is packaged within the cannula body.
Model 24009: The DLP Aortic Root Cannula with Vent Line consists of a soft, flexible, thin-wall tip permanently attached to a flexible Y-type adapter. Flexible tubing is permanently attached to both the inlet and vent port of the Y-type adapter. The cannula inlet fitting is a female luer and the vent port fitting (outlet) is a slip-on connector for 0.48 cm (3/16 in) to 0.64 cm (1/4 in) Inner Diameter (I.D.) tubing. The introducer is packaged within the cannula body.
Model 15004: The DLP Cardioplegia Adapter with Pressure Port consists of flexible tubing, luer connections, and a latex-free rubber septum. The end that terminates with a male luer connects to the cardioplegia cannula and the other end connects to the cardioplegia administration set. A latex-free rubber septum provides access for a pressure monitoring needle near the connection to the cardioplegia cannula.
Model 25009 and 25010: The DLP Pressure Monitoring Extension Line Adapter is 1.8 m (6 ft) in length with a locking male luer fitting on one end, and either a locking female luer fitting (Model 25009) or a locking male luer fitting (Model 25010) on the other end.
All are provided sterile, nonpyrogenic, and for single use.
The provided document is a 510(k) premarket notification letter from the FDA to Medtronic, Inc. regarding various DLP™ Aortic Root Cannulas and Adapters.
This document does not contain information about:
- Acceptance criteria for device performance (beyond the general regulatory requirements for substantial equivalence).
- Specific study designs, sample sizes, or data provenance.
- The number or qualifications of experts, ground truth establishment, or adjudication methods for a test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect sizes of human readers improving with AI assistance.
- Standalone algorithm performance.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Any details about training sets (sample size or ground truth establishment).
The FDA letter and accompanying summary focus on demonstrating "substantial equivalence" of the modified devices to existing predicate devices based on intended use, technological characteristics, operating principle, design features, base materials, and shelf life. This is a regulatory pathway for marketing devices that are similar to already legally marketed devices, and typically involves verifying that changes do not alter performance specifications in a way that would raise new questions of safety or effectiveness. It does not typically require detailed clinical performance studies akin to those you might find for novel AI/ML devices or drugs, which would involve the type of acceptance criteria and study data you've requested.
Therefore, I cannot provide the requested information from the given text. The document asserts that the devices are substantially equivalent, implying that their performance aligns with the predicate devices, but it does not specify quantitative performance metrics or the studies used to demonstrate those metrics as you've requested.
§ 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).