(110 days)
The TandemHeart Veno-Venous Cannula Set is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.
The TandemHeart Veno-Venous Cannula Set consists of two components: a 29 Fr. Dual lumen Veno-Venous Cannula and a 13 Fr. Introducer. The Introducer is designed to accept a standard 0.038 inch guidewire. The TandemHeart Veno-Venous Cannula Set is intended as a single patient, single use, sterile device.
The TandemHeart Veno-Venous Cannula (Figure 1) consists of two distinct lumens with a wire-reinforced cannula body. The inner lumen is located entirely within the outer lumen forming two concentric channels.
The distal section (inner lumen/cannula) of the cannula body has six side holes near the distal tip opening. The proximal sections of each lumen are clear and not wire-reinforced to allow visualization of blood and to enable clamping to prevent blood flow during setup and removal of the cannula from the extracorporeal circulatory support equipment (see Figure 1). A non-vented barbed connector is affixed to both proximal ends (inner/distal and outer/proximal lumens) of the cannula and allow for connection of standard 3/8 inch blood circuit tubing for subsequent connection to extracorporeal circulatory support equipment. The cannula has printed insertion depth markings every 10 centimeters from 10 to 30 cm followed by every 2 centimeters for the remainder of the insert-able length, measured from the distal end. The cannula also has a suture wing that can be used for securing the cannula in place to the patient.
The introducer (Figure 2) consists of a tube with a hub. The introducer fits inside the inner lumen of the cannula during insertion of the cannula/introducer assembly. The introducer is used to advance the cannula over a guidewire and facilitate cannula placement within the target vessel. The introducer has a hub at its proximal end to manage introducer insertion and removal from the cannula. The hemostasis cap minimizes blood loss when the cannula/introducer assembly is inserted into the target vessel. The introducer body is constructed from radiopaque material for visualization under fluoroscopy.
The provided document is a 510(k) summary for the TandemHeart Veno-Venous Cannula Set. This type of regulatory submission is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving efficacy or performance against specific clinical acceptance criteria in the manner requested.
Therefore, the document does not contain the requested information about acceptance criteria, a human clinical study, or AI performance metrics.
Here's what can be extracted from the document regarding the device's evaluation, and why it doesn't align with the request:
1. A table of acceptance criteria and the reported device performance:
- This information is not present. The document discusses general performance testing but does not detail specific acceptance criteria or quantitative performance tables.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document describes "non-clinical performance testing" using "in-vitro system capacity testing and flow vs. pressure drop (HQ)." This indicates it was not a human clinical study and therefore has no human "test set" in the sense of a patient cohort. The "sample size" would refer to the number of devices or experimental setups, which is not specified.
- Data provenance (country, retrospective/prospective) is not applicable as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as there was no human clinical "test set" requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable as there was no human clinical "test set" and thus no adjudication of clinical outcomes.
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 device is a medical cannula, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI performance metrics are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical performance testing, the "ground truth" would be established by engineering and chemical principles, likely against a set of predetermined engineering specifications for flow rate, pressure drop, flexibility, strength, biocompatibility, etc. These specific "ground truths" and their methods are not detailed in the summary.
8. The sample size for the training set:
- Not applicable as there is no AI component or machine learning "training set."
9. How the ground truth for the training set was established:
- Not applicable as there is no AI component or machine learning "training set."
Summary of what is available from the document:
The document states that "Non-clinical performance testing was conducted to demonstrate substantial equivalence of flow characteristics between the TandemHeart Veno-Venous Cannula and the predicate, Medtronic Avalon Elite." It also mentions "Flexibility, strength, biocompatibility, in-vitro hemolysis, leak testing, sterilization, and shelf life" were addressed.
The conclusion drawn from this testing was that "Based on the performance test results and data from the predicate devices, the TandemHeart Veno-Venous Cannula was found to meet established design input requirements and thus to be substantially equivalent to the predicate Avalon Elite Dual Lumen Veno-Venous Cannula."
In conclusion, this document describes the regulatory clearance of a physical medical device (a cannula) based on substantial equivalence to predicate devices, primarily through non-clinical, in-vitro testing. It does not involve AI, human clinical trials with specific acceptance criteria as you've outlined, or ground truth established by medical experts for a diagnostic task.
§ 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).