(29 days)
The Left Atrial Pressure Monitoring Catheters are intended to be used solely in conjunction with a standard hemodynamic pressure monitoring system to obtain continuous central vascular pressures via the left atrium during and/or after cardiac surgery.
The Edwards Lifesciences Left Atrial Pressure Monitoring Catheters consist of a radiopaque catheter bonded to a 3-way stopcock. Each catheter is marked at 1, 2, 3, and 4 centimeters for reference and is fitted over a pencil point stainless steel stylet. The proximal end of the stylet terminates in a male luer lock hub which is engaged by the proximal female port of the stopcock. Each catheter is provided with a moveable suture anchor. The devices are provided sterile, they are non-pyrogenic and they are intended for single use only.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test Performed | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993 | Met pre-established acceptance criteria |
| Hemocompatibility | Hemolysis Assay and clotting time coagulation assay | Met pre-established acceptance criteria |
| Stopcock Handle Rotation Torque | Tensile test of the stem/core and the stopcock housing | Met pre-established acceptance criteria |
| Stopcock Handle Leak Testing | Inspection for defects after exposure to dynamic water flow and manipulation of the stopcock stem/core | Met pre-established acceptance criteria |
| Stopcock Flow Redirection Testing | Inspection of proper liquid directional flow as indicated on stopcock lever | Met pre-established acceptance criteria |
| Stopcock Leakage Testing | Pressure Decay within the stopcock stem/core | Met pre-established acceptance criteria |
| Stopcock Visual Inspection | Evaluated for component damage and discoloration | Met pre-established acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each functional/safety test (e.g., number of catheters tested for biocompatibility, leak testing, etc.). It mentions that the "performance data demonstrate equivalence" to the predicate device and that "all necessary verification steps met pre-determined acceptance criteria."
The data provenance is not explicitly stated in terms of country of origin but is related to the manufacturing and testing by Edwards Lifesciences, LLC. The studies appear to be prospective in nature, as they involve testing the newly developed device against pre-established criteria.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of information (number and qualifications of experts for ground truth) is only relevant for studies where human interpretation or judgment is part of the "ground truth" (e.g., image analysis, clinical diagnosis). The described tests are functional and safety tests of a physical medical device, not a diagnostic algorithm, so there is no mention of experts establishing a "ground truth" in this context. The acceptance criteria are based on quantitative measurements and industry standards (e.g., ISO 10993).
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies involving expert consensus for ground truth. Since the reported studies are functional and safety tests of a physical device, this concept does not apply. The acceptance criteria are objective and predefined.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging or other decision-support AI systems where human readers interpret cases. The described studies are for a physical catheter device. The comparative analysis mentions that "it has been demonstrated that the Left Atrial Pressure Monitoring Catheter is comparable to the predicate device in intended use and other labeling, fundamental scientific technology, material types, principles of operation and functional performance evaluations," but this refers to the overall substantial equivalence, not an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
No, a standalone study (in the context of an algorithm's performance) was not done. This device is a physical medical instrument, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the functional and safety tests was based on objective, quantifiable measurements and adherence to established industry standards (e.g., ISO 10993 for biocompatibility) and predefined specifications for mechanical and performance characteristics (e.g., torque, leak rates, flow redirection).
8. The Sample Size for the Training Set
This concept of a "training set" is applicable to machine learning or AI models. Since the device is a physical catheter, there is no training set in the AI sense. The design and manufacturing processes are validated through engineering and quality control, not by training an algorithm on a dataset.
9. How the Ground Truth for the Training Set was Established
As there is no training set for an AI model, this question is not applicable. The "ground truth" for ensuring the device's design and manufacturing quality relies on validation against engineering specifications, material properties, and relevant standards.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).