(171 days)
The Sams™ Soft-Flow Extended Aortic Cannula is indicated for perfusion of the assending aorta during cardiopulmonary bypass surgery for up to 6 hours of use.
The Sams™ Soft-Flow® Extended Aortic Cannula provides a conduit for the flow of patient blood within the extracorporeal circuit during cardiopulmonary bypass surgery. The or parent of the Sams™ Soft-Flow® Extended Aortic Cannula allows patient blood to re-enter the body after the blood has routed through an extracorporeal circuit for blood oxygenetion. The connila consists of a tubular conduit with a tip that can be positioned into the patient's anatomy (ascending aorta) to allow the blood to re-enter the vascular blood stream.
Here's a breakdown of the acceptance criteria and the study information for the Sarns™ Soft-Flow® Extended Aortic Cannula, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Evaluation | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Force at Break | Satisfy appropriate specifications (implied: at least equal to predicate device) | Passed pre-determined acceptance criteria |
| Liquid and Air Leak | Satisfy appropriate specifications (implied: no leaks) | Passed pre-determined acceptance criteria |
| Ink Adhesion | Satisfy appropriate specifications (implied: maintains legibility) | Passed pre-determined acceptance criteria |
| Hemolysis | Satisfy appropriate specifications (implied: low or acceptable levels of hemolysis; straight tip design generally produces slightly lower pressure drop, thus less potential for hemolysis than predicate's angled tip) | Passed pre-determined acceptance criteria |
| Pressure Drop | Satisfy appropriate specifications (implied: low resistance to flow; straight tip design generally produces slightly lower pressure drop) | Passed pre-determined acceptance criteria |
| Exit Velocity | Satisfy appropriate specifications (implied: comparable to predicate device) | Passed pre-determined acceptance criteria |
| Biocompatibility | Full support of FDA General Program Memorandum #G95-1 / ISO 10993 (implied: no adverse biological reactions) | Passed pre-determined acceptance criteria |
Note on Acceptance Criteria: The document states that "performance studies were conducted to ensure...passed pre-determined acceptance criteria." However, the specific quantitative acceptance criteria for each test are not explicitly detailed in the provided text. They are implied to be "appropriate device performance specifications" and to ensure "no appreciable differences in performance between the subject devices and the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set as it refers to these as "bench studies" and "performance evaluations" rather than a clinical human-subject study. The data provenance is retrospective in the sense that the evaluations were done on already manufactured devices as part of a premarket notification (510(k)) process. The location of the testing is not explicitly stated, but it would have been conducted by Terumo Cardiovascular Systems Corporation or a contracted lab. There is no mention of country of origin for test data in the context of human subjects, as no clinical studies were performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a medical device regulatory submission for a physical device, and the "ground truth" was established through engineering and laboratory testing against predetermined specifications, not through expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this was a medical device regulatory submission for a physical device, not related to expert review of data that would require adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This device is an aortic cannula for cardiopulmonary bypass surgery. It is a physical medical device and does not involve AI or human "readers" in the context of diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This device is an aortic cannula, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance evaluations was established by engineering specifications and industry standards for medical devices (e.g., ISO 10993 for biocompatibility). These criteria are designed to ensure the device performs safely and effectively for its intended use, comparable to legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this physical medical device. The "training" for such devices typically involves design iterations and prototyping, which are then subject to the performance evaluations described.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no "training set" in the AI or clinical study sense, this question does not apply. The analogous process for a physical device would be the iterative design and manufacturing process guided by established engineering principles and regulatory requirements.
§ 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).