(30 days)
These devices are to be used by a trained physician only. Cannulate vessels, perfuse vessels or organs, and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriately-sized cannula within the vessel for cardiopulmonary bypass. The Bio-Medicus™ cannula (18-cm [7.09-in] tip length models) may be used in either the femoral position as an arterial delivery cannula or in the jugular position as venous return cannula. This product is intended for use up to 6 hours.
The Bio-Medicus™ Adult Cannulae and Introducer is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriate sized cannula within the vessel for cardiopulmonary bypass.
The Bio-Medicus™ Adult Cannulae and Introducer set consists of adult arterial and venous cannulae and introducer. This submission will focus on the adult venous cannulae only. The adult venous cannulae are all supplied sterile, and non-pyrogenic and are for single use only.
The adult venous cannula consists of:
- o Polyurethane cannula with stainless steel wire-wound multi-port body
- o Non-vented 3/8-in connector
- The overall length of the cannulae is 25.6-in and 30-in o
- Insertion marks that aid in positioning the cannula ●
- o Repositionable suture ring that is radiopaque
The one-piece non-phthalate PVC introducers included with these cannulae have an elongated taper for dilation over a longer distance.
The Bio-Medicus™ Adult Cannulae and Introducer package contains a securement clip which can be used near the insertion site for securement of the cannula body which aides in securement as well as an aide for physician organization. The large venous models (23-25 Fr) also contain a 3/8-in x ½-in tubing adapter with an attached length of 3/8-in tubing to allow connection to a ½in cardio pulmonary bypass circuit.
This new Bio-Medicus™ Adult Cannulae and Introducer set consists of increased number of drainage side holes along the insertable length and the increase of depth markings from every 10cm to every 5cm to further aid in positioning of the cannula. The change is taking place on the 15 French (F) through 25 F adult venous Bio-Medicus cannulae.
The provided FDA 510(k) summary (K180453) describes a device, the Bio-Medicus™ Adult Cannulae and Introducer. However, it does not contain information related to a study that establishes acceptance criteria for performance metrics typically associated with AI/ML-driven devices, such as sensitivity, specificity, or reader improvement.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench) testing. The acceptance criteria and performance data are related to the physical and functional aspects of the cannulae, not diagnostic accuracy or AI performance.
Therefore, many of the requested details (sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth types, training set sample size, and ground truth for training set) are not applicable to this submission as it is not for an AI/ML medical device.
Here's the information that can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Blood Trauma Testing | Demonstrate acceptable blood compatibility/minimal trauma | Verified (implied to meet acceptable standards) |
| Bioburden Testing | Meet sterility requirements for medical devices | Verified (implied to meet acceptable standards) |
| Pressure Drop Testing | Ensure efficient fluid flow through the cannulae | Verified (implied to meet efficient flow standards) |
| Cannula Testing - Kink During Perfusion | Maintain patency during use (no kinking under normal perfusion conditions) | Verified (implied to maintain patency) |
| Depth Marking Presence | Markings are present and aid in positioning as intended | Verified (implied that markings are present and functional) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as the studies are non-clinical bench tests. The concept of a "test set" in the context of clinical data or AI/ML performance is not applicable here.
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)
This information is not applicable as the studies are non-clinical bench tests, and ground truth in the context of expert diagnosis is not relevant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the studies are non-clinical bench tests.
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
This information is not applicable. This is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. For bench testing, the "ground truth" refers to engineering specifications and performance standards against which the device is tested.
8. The sample size for the training set
This information is not applicable. This is not an AI/ML device, and therefore no training set was used.
9. How the ground truth for the training set was established
This information is not applicable. This is not an AI/ML device.
§ 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).