(149 days)
Chase Medical aortic root cannula is intended for use in conjunction with cardiopulmonary bypass surgery for delivery of cardioplegia solution. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure.
During open-heart surgery, the patient's heart is temporarily stopped to allow the surgeon a bloodless, still surface in order to complete the surgical repair. The process of stopping the heart is often achieved by infusing into the heart a solution containing various drugs which act to stop and preserve the heart. This cardioplegia solution is delivered into the heart by way of the aorta and/or into vein grafts. The Chase Aortic Root Cannula is placed into the ascending aorta to deliver cardioplegia solution to the heart. The cannula may be used to aspirate air from the aorta at the conclusion of the bypass procedure.
The Aortic Root Cannula consists of flexible polyvinyl chloride tubing permanently attached to both the polycarbonate inlet and soft, flexible, polyvinyl chloride tip. Tip sizes include 12 gauge. The inlet fitting is a female luer fitting. The suture ring is soft polyvinyl chloride. The introducer is stainless steel and packaged within the cannula body. The vented Aortic Root Cannula has polyvinyl chloride tubing with a polycarbonate vent line adaptor and vented tip sizes include 12 gauge and 14 gauge.
This looks like a medical device K964198 "Aortic Root Cannula" submission to the FDA, not an AI/ML device. Therefore, a lot of the requested information (e.g., ground truth, MRMC study, training set size) is not applicable.
However, I can extract the acceptance criteria and the "study" (functional testing conducted) that proves the device meets these criteria based on the provided text.
Here's the breakdown of the information that is applicable:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Leak Test Requirements: | No leaks at 10 psi air on Chase device at 4°C and 40°C |
| Tubing Bond Strength: | Exceeds 10 lb. tensile strength @ 4°C and 40°C |
| Luer Connections: | Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Tape Fittings |
| Package Integrity: | Tyvek/Polymylar passed burst test per ASTM F1140-88 |
| Shipping & Distribution Testing: | Per National Safe Transit Ass. vibration and drop tests |
| Accelerated Aging: | Two year shelf life |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The functional testing implies testing on a sufficient number of devices to demonstrate the performance for each criterion, but specific numbers are not given.
- Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). This refers to laboratory and physical testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is not an AI/ML diagnostic or measurement device that requires expert ground truth establishment in a clinical context. The "ground truth" for these tests are objective physical and engineering standards.
4. Adjudication method for the test set:
- Not applicable. The tests are objective physical measurements against established standards, not subjective interpretations requiring 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 is not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used:
- The "ground truth" for these tests are objective engineering standards (e.g., "no leaks at 10 psi air," "exceeds 10 lb. tensile strength," "Meets ANSI/HIMA MD70.1-1983," "passed burst test per ASTM F1140-88").
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).