(74 days)
The CentriMag Drainage Cannula is intended to be used as a venous drainage cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
The CentriMag Drainage Cannula Kit consists of a sterile, single-use, disposable, noncoated, Poly Vinyl Chloride (PVC) Cannula and the following accessories:
- A) One Cap with Tape
B) One Apical Sewing Ring Handle
C) One Apical Sewing Ring
D) One Apical Support Cuff
E) Two Stabilizer Rings - Large
F) Two Stabilizer Rings - Medium
Here's an analysis of the provided 510(k) summary regarding the Levitronix CentriMag Drainage Cannula Kit, focusing on the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Explicit or Implied) | Reported Device Performance |
|---|---|---|
| Physical Testing | Pre-established acceptance criteria (details not provided) | Met pre-established acceptance criteria |
| Sterilization Validation | Pre-established acceptance criteria (details not provided) | Met pre-established acceptance criteria |
| Biocompatibility | Pre-established acceptance criteria (details not provided) | Met pre-established acceptance criteria |
| Shelf Life Studies | Pre-established acceptance criteria (details not provided) | Met pre-established acceptance criteria |
| Transportation | Pre-established acceptance criteria (details not provided) | Met pre-established acceptance criteria |
| Hemolysis (in vitro) | Pre-established acceptance criteria (details not provided for specific thresholds of hemolysis) | Met pre-established acceptance criteria |
| Flow versus Pressure Drop | Pre-established acceptance criteria (details not provided for specific flow rates and pressure drops) | Met pre-established acceptance criteria |
| Overall Goal | Substantial equivalence to the predicate device (Edwards Lifesciences Venous Drainage Cannula, K870109) | Demonstrated substantial equivalence through functional testing |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample sizes used for any of the functional tests (Physical Testing, Sterilization Validation, Biocompatibility, etc.).
It also does not mention data provenance in terms of country of origin or whether the data was retrospective or prospective. Given that no clinical testing was performed, the data is likely derived from bench or in-vitro tests conducted internally by Levitronix LLC or its contractors.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this submission. The studies described are functional (bench/in-vitro) tests, not studies requiring expert interpretation of clinical data or images to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as there are no expert interpretations or clinical data requiring adjudication mentioned in the summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed for the CentriMag Drainage Cannula Kit. The summary explicitly states: "Clinical testing was not performed for the CentriMag Drainage Cannula Kit." This type of study would involve human readers (e.g., clinicians) evaluating cases with and without AI assistance, which is irrelevant for this type of medical device submission (a cannula).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable in the context of this device. A "standalone algorithm" refers primarily to AI/ML software devices. The CentriMag Drainage Cannula Kit is a physical medical device (a catheter/cannula) used in an extracorporeal bypass circuit, not an algorithm. The performance detailed is the physical and functional performance of the device itself.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI/ML medical devices (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. For this physical cannula device, the "ground truth" for the functional tests would be established by:
- Engineering specifications and design requirements: For physical properties, flow dynamics, and material characteristics.
- Established standards and regulations: For sterilization, biocompatibility, and transportation integrity.
- Predicate device performance data: The performance of the predicate device (Edwards Lifesciences Venous Drainage Cannula) would serve as a benchmark for comparison to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. The CentriMag Drainage Cannula Kit is a physical medical device and does not involve an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above (no AI/ML algorithm or training set).
§ 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).