(314 days)
The CTS Voyager Quad Cannula is intended for use in perfusion and occlusion of the ascending aorta during cardiopulmonary bypass. The cannula functions to occlude the ascending aorta when the balloon is inflated. The main lumen of the cannula provides delivery of arterial perfusion. The side lumen allows delivery of cardioplegia to arrest the heart and venting of fluid from the aortic root during cardiac surgery.
The CTS Voyager Quad Cannula is a three lumen cannula with an elastomeric balloon near the distal tip for occluding the ascending aorta in order to partition the aortic root from arterial circulation. The compliant balloon expands to occlude a range of aorta sizes. The large central lumen of the cannula serves to provide arterial perfusion. The side lumen serves two functions: delivery of cardioplegic solution to the aortic root and venting of fluid from the aortic root during cardiac surgery. The remaining lumen serves as a conduit for balloon inflation and deflation. The marker on the cannula outer shaft indicates the insertion depth. The clamp ring provided on the cannula allows the cannula to be fixed into position.
The provided text describes a 510(k) premarket notification for a medical device, the CTS Voyager Quad Cannula. It focuses on establishing substantial equivalence to existing predicate devices and does NOT include a "study that proves the device meets the acceptance criteria" in the way one might expect for an AI algorithm or diagnostic tool.
Therefore, many of the requested categories are not applicable to this type of submission. Here's a breakdown based on the information provided:
Acceptance Criteria and Device Performance for CTS Voyager Quad Cannula
This 510(k) submission is for a physical medical device (a cannula), not an AI/ML algorithm or a diagnostic test with performance metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are related to functional performance and safety as demonstrated through bench and animal testing. The "device performance" reported is that the device "performs as designed and is suitable for its intended use."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred from text) | Reported Device Performance (Inferred from text) |
|---|---|---|
| Functional Performance | Ability to perfuse and occlude the ascending aorta during cardiopulmonary bypass. | "The results of the testing verified that the Voyager Quad Cannula performs as designed and is suitable for its intended use." Mentions specific functions: balloon inflation for occlusion, main lumen for arterial perfusion, side lumen for cardioplegia delivery and venting. |
| Safety | No new issues of safety compared to predicate devices. | "Any differences between the Voyager Quad Cannula and its predicate devices do not raise any new issues of safety or effectiveness." |
| Biocompatibility | Suitable for contact with human tissue and blood (implied for medical devices of this nature). | Not explicitly detailed in this summary, but would be part of standard device testing ensuring "suitability for its intended use" and "no new issues of safety." |
| Durability/Integrity | Maintaining structural integrity and function during intended use (implied from "performs as designed"). | Not explicitly detailed, but integral to "performs as designed." |
| Occlusion Range | Compliant balloon expands to occlude a range of aorta sizes. | "The compliant balloon expands to occlude a range of aorta sizes." (This implicitly confirms it meets the design intent for occlusion range). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in terms of numerical count for bench or animal testing.
- Data Provenance: The text states, "Functional bench testing and animal testing has been conducted." The country of origin for the data is not specified but would presumably be conducted by CardioThoracic Systems, Inc. in the USA.
- Retrospective or Prospective: These types of tests (bench and animal) are inherently prospective studies designed to evaluate the device's performance under controlled conditions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable (N/A): This is a submission for a physical medical device. The "ground truth" is established by direct physical measurement and observation during bench and animal testing, evaluated by engineers, scientists, and veterinary staff, rather than by human expert interpretation of data points for an AI algorithm.
4. Adjudication Method for the Test Set
- Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies among human readers agreeing on a "ground truth" for diagnostic or AI studies. For physical device testing, results are typically determined by direct measurement, observation, and established acceptance criteria for functional performance and safety, with no "adjudication" in this sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No: An MRMC comparative effectiveness study is not applicable to a physical medical device like a cannula. These studies are used for evaluating diagnostic performance, often for AI systems compared to human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable (N/A): This is for a physical device, not an algorithm.
7. The Type of Ground Truth Used
- Physical Performance and Safety Data: The "ground truth" for this device is derived from direct measurements and observations during functional bench testing and animal studies. This includes confirming the physical capabilities of the cannula (e.g., balloon inflation, fluid delivery/venting) and its safety profile by observing its effect on biological systems in animal models. It's essentially the verifiable physical and biological responses to the device's operation.
8. The Sample Size for the Training Set
- Not Applicable (N/A): This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable (N/A): This is not an AI/ML device, so there is no "training set" or ground truth establishment for it.
§ 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).