(97 days)
The Femoral Arterial Cannula and Introducer is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment for a duration of six hours or less. The cannula introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.
The TandemHeart Femoral Arterial Cannula Set consists of two components: a 17 Fr. Femoral Arterial Cannula and a 12 Fr. Introducer. The device is intended to cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal circulatory support equipment. The product is intended to be single patient, single use, sterile device. The cannula has multiple side holes in addition to the tip opening for unimpeded flow of blood at the distal end and a vented barbed fitting at the proximal end to enable the connection of 3/8" tubing. Radiopaque markers are embedded at the distal tip of the cannula, and the cannula body is wire-reinforced for visualization under fluoroscopy. Insertion depth markings have been incorporated in the cannula body working length from 5 to 17 cm measured from the distal tip. The cannula includes a suture wing to provide a means for securing the cannula to the patient and a stop component to minimize cannula insertion depth beyond its working length. Printing on the proximal region of the cannula indicates the area where a clamp should be applied if needed during the set-up or removal process. The 12 Fr. introducer is provided to facilitate placement of the arterial cannula, within the target vessel, and is designed with a tapered distal tip. The introducer proximal end contains a luer hub to aid in the removal of the introducer. The introducer body is also constructed of a radiopaque material for visualization under fluoroscopy. The introducer includes a hemostasis cap that provides the interface between the cannula proximal connector and introducer body. The hemostasis cap aids in minimizing blood loss during the insertion of the cannula/introducer assembly into the target vessel.
The provided text describes the 510(k) summary for the TandemHeart Femoral Arterial Cannula Set, focusing on its substantial equivalence to a predicate device rather than a study proving the device meets specific acceptance criteria in the context of an AI/human reader study.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered from the provided text, as they pertain to clinical studies or AI/diagnostic device performance evaluations that are not present. The document focuses on non-clinical performance testing to demonstrate substantial equivalence, which is a different type of evaluation.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| Non-Clinical Performance | In-vitro Hemolysis Testing | Demonstrated substantial equivalence to predicate | Met established design input requirements and performed substantially equivalent to predicate. |
| In-vitro System Capacity Testing | Demonstrated substantial equivalence to predicate | Met established design input requirements and performed substantially equivalent to predicate. | |
| Flow vs. Pressure Drop (HQ) | Demonstrated substantial equivalence to predicate | Met established design input requirements and performed substantially equivalent to predicate. | |
| Kink Testing | Demonstrated substantial equivalence to predicate | Met established design input requirements and performed substantially equivalent to predicate. | |
| Leak Testing | Demonstrated substantial equivalence to predicate | Met established design input requirements and performed substantially equivalent to predicate. | |
| Deflection Testing | Demonstrated substantial equivalence to predicate | Met established design input requirements and performed substantially equivalent to predicate. | |
| Material Biocompatibility | Biocompatibility of suture wing and stop | Biocompatible | Found to be biocompatible. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be determined from the provided text. The text mentions "non-clinical performance testing" and "in-vitro" tests, but does not specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be determined from the provided text. This information is relevant for clinical or diagnostic studies, not the non-clinical engineering tests described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be determined from the provided text. This is relevant for expert-based ground truth establishment, which is not described.
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
- No, an MRMC study was not done. The device itself is not an AI/diagnostic tool, but a medical device (cannula).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone algorithm performance study was not done. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical performance tests, the "ground truth" would be established engineering specifications and benchmarks against the predicate device. For biocompatibility, it refers to standard biological response criteria. There is no expert consensus, pathology, or outcomes data mentioned in the context of ground truth.
8. The sample size for the training set
- Cannot be determined from the provided text. There is no "training set" in the context of this type of device submission.
9. How the ground truth for the training set was established
- Cannot be determined from the provided text. There is no "training set" or corresponding ground truth establishment process described.
§ 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).