(22 days)
These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.
The Malleable Single Stage Venous Cannula with Carmeda® BioActive Surface, is designed for use with cardiopulmonary bypass as a venous drainage cannula. The malleability feature allows the cannulae to be shaped and positioned to meet each customer's specific needs. The Carmeda® BioActive Surface adds a heparin based coating to the cannulae surface.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study details for the Malleable Single Stage Venous Cannula with Carmeda® BioActive Surface:
Overview:
This 510(k) submission (K033264) is for a Malleable Single Stage Venous Cannula with a Carmeda® BioActive Surface, intended for use in cardiopulmonary bypass surgery. The submission focuses on demonstrating substantial equivalence to previously marketed predicate devices. The study described is primarily in vitro testing to establish the performance characteristics of the modifications (the Carmeda® BioActive Surface) compared to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in a quantitative or formal manner typically seen for clinical endpoints or diagnostic accuracy. Instead, the "performance" is demonstrated through various in vitro tests establishing that the modified device performs comparably to or within acceptable limits for a device of its kind.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Visual Integrity | "In vitro visual... testing on Carmeda® coated devices was used to establish the performance characteristics of the modifications." (Implies the device maintains visual integrity when coated.) |
| Coating Coverage | "Coverage... testing on Carmeda® coated devices was used to establish the performance characteristics of the modifications." (Implies adequate and consistent coating coverage was achieved.) |
| Bioactivity (Heparin function) | "Bioactivity... testing on Carmeda® coated devices was used to establish the performance characteristics of the modifications." (Implies the heparin-based coating maintains its intended biological activity, likely related to anticoagulation properties.) |
| Leaching (Coating stability) | "Leaching... testing on Carmeda® coated devices was used to establish the performance characteristics of the modifications." (Implies the heparin coating does not leach off at an unacceptable rate, which would compromise its effectiveness or safety.) |
| Functional Performance | "Functional... testing on Carmeda® coated devices was used to establish the performance characteristics of the modifications." (This is a broad category, but likely refers to mechanical integrity, flow characteristics, or other physical performance measures relevant to venous cannulae, ensuring the added coating does not negatively impact the primary function of the cannula.) |
| Biocompatibility | "Biocompatibility testing on Carmeda® coated devices was used to establish the performance characteristics of the modifications." (Implies the device, with its coating, meets established standards for biological safety, such as cytotoxicity, sensitization, irritation, etc., and does not elicit undesirable biological responses when in contact with blood/tissue.) |
| Substantial Equivalence | "Medtronic Perfusion Systems has demonstrated that the Malleable Venous Cannulae with Carmeda® BioActive Surface are substantially equivalent to the predicate devices based upon design, test results, and indications for use." (Overall conclusion, based on all the above tests, that the device is as safe and effective as the predicate.) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of cannulae or test samples used for each of the "in vitro visual, coverage, bioactivity, leaching, functional and biocompatibility testing."
- Data Provenance: The studies were "in vitro" testing, meaning they were conducted in a laboratory setting, not on human subjects. No country of origin is explicitly mentioned, but the submitter is based in the USA (Brooklyn Park, MN). The data is by nature retrospective in the sense that it's generated for regulatory submission, rather than a prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to the provided study description. The evaluations were "in vitro" tests, relying on scientific methodologies and established standards rather than expert clinical consensus for "ground truth."
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
This information is not applicable. The study involves in vitro laboratory tests, not human assessments requiring adjudication.
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. The device described is a medical cannula, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable. The device is a physical medical device, not an algorithm, so the concept of standalone performance does not apply.
7. The Type of Ground Truth Used (Expert Concensus, Pathology, Outcomes Data, Etc.)
The "ground truth" for the in vitro tests would be established by:
- Standardized test methods and protocols: For aspects like visual inspection, flow rates, coating thickness.
- Chemical/Biological assays: For bioactivity (e.g., anti-Xa activity for heparin), leaching assays (measuring leached heparin concentration), and biocompatibility (e.g., ISO 10993 series standards for cytotoxicity, hemolysis, etc.).
- Engineering specifications: For functional performance, comparing against design requirements and predicate device performance.
8. The Sample Size for the Training Set
This information is not applicable. The device is not an AI/machine learning algorithm, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of 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).