(265 days)
The SMARxT Tubing and Connectors, a part of the Heart/Lung Perfusion Pack, are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.
The SMARxT Tubing and Connectors, subjects of this application are part of the Heart/Lung Perfusion Pack (K881330), a customized system of tubing and other devices built to user specifications designed for use during surgery requiring cardiopulmonary bypass.
This is a 510(k) summary for the SMARxT Tubing and Connectors, a medical device used in cardiopulmonary bypass. The document states that the modified device, which uses a different surface treatment material (Tegomer additive material is changing from Tegomer H-Si6441 P), is substantially equivalent to its predicate device. This determination is based on non-clinical testing.
Here's the detailed breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biological Evaluation | Cytotoxicity | In accordance with ISO 10993-1 and FDA guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" | Successfully met all acceptance criteria. |
| Direct and Indirect Hemolysis ("Hemolysis") | In accordance with ISO 10993-1 and FDA guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" | Successfully met all acceptance criteria. | |
| Functional / Performance Testing | Blood pathway integrity and coverage | Ensure the blood pathway remains intact and adequately covered, presumably to prevent leaks or biological interaction. Specific quantitative criteria are not provided in this summary. | Successfully met all acceptance criteria. |
| Surface Modification Integrity | Ensure the integrity and proper adhesion/presence of the surface modification (Tegomer) throughout the expected use. Specific quantitative criteria are not provided in this summary. | Successfully met all acceptance criteria. | |
| Connection testing | Ensure secure and functional connections between tubing and connectors. Specific quantitative criteria are not provided in this summary. | Successfully met all acceptance criteria. | |
| Life to failure testing | Evaluate the device's durability and ability to withstand stress over its intended lifespan (up to six hours in this case). Specific quantitative criteria are not provided in this summary. | Successfully met all acceptance criteria. | |
| Spallation | Evaluate the shedding of particles from the material, which is critical in devices directly contacting blood. Specific quantitative criteria are not provided in this summary. | Successfully met all acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes (number of units tested) for each of the in vitro tests. It only states that "in vitro testing was performed."
- Data Provenance: The data provenance is retrospective in the sense that it's a submission for regulatory clearance based on testing already completed. The tests were performed by Livanova USA Inc., presumably in a controlled laboratory environment. The country of origin of the data is not explicitly stated but can be inferred to be from the manufacturer's testing facilities, likely in the US or Europe given Livanova's global presence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This section is not applicable as the evaluation was based on non-clinical (in vitro) testing against established standards and internal performance specifications, not human expert interpretation of data.
4. Adjudication Method for the Test Set
This section is not applicable as the evaluation was based on non-clinical (in vitro) testing against established standards and internal performance specifications. There was no need for human adjudication of test results in the way it might apply to image-based diagnostic AI.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is hardware (tubing and connectors) and does not involve AI or human readers for its function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not conducted. This device is hardware and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device, in the context of its substantial equivalence determination, was established through adherence to recognized medical device standards and rigorous in vitro performance testing. This includes:
- International Standard ISO 10993-1: "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."
- FDA Guidance Document: "Use of International Standard ISO 10993-1,
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management processof September 4, 2020." - Internal performance specifications/requirements: The specific acceptance criteria for "Blood pathway integrity and coverage," "Surface Modification Integrity," "Connection testing," "Life to failure testing," and "Spallation" would have been defined by the manufacturer based on the predicate device's performance and clinical requirements for cardiopulmonary bypass tubing.
Essentially, the ground truth is that the device must perform equivalently to its predicate and meet established safety and performance benchmarks for its intended use.
8. The Sample Size for the Training Set
Not Applicable. This device is hardware and does not involve machine learning or an AI algorithm, therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set.
§ 870.4390 Cardiopulmonary bypass pump tubing.
(a)
Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).