(88 days)
The chest drainage tubing is intended to serve as a conduit for the flow of body fluids that are removed from the patient, via vacuum, and delivered to a reservoir during cardiopulmonary bypass procedures.
The chest drainage tube is piece of flexible polyvinylchloride tubing that is used as a conduit for body fluids suctioned from the chest cavity and moved into a reservoir following cardiopulmonary bypass procedures. The tubing is a 40 durometer tube with an inside diameter of 0.375" and an outside diameter of 0.562".
The provided text describes a 510(k) submission for "Chest Drainage Tubing" and establishes its substantial equivalence to a predicate device. This type of submission relies on demonstrating similarity to an already cleared device, rather than conducting new clinical trials with acceptance criteria based on performance metrics like sensitivity or specificity.
Therefore, many of the requested points regarding acceptance criteria, study design, and ground truth are not applicable in this context. The "acceptance criteria" here are that the new device is "substantially equivalent" to the predicate device in terms of intended use, design, technology/principle of operation, materials, and performance, and that it raises no new issues of safety and effectiveness.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (vs. Predicate Device) |
|---|---|
| Intended Use | Substantially equivalent to the cleared Gish Biomedical Tubing (K870792). Intended to serve as a conduit for the flow of body fluids removed from the patient, via vacuum, and delivered to a reservoir during cardiopulmonary bypass procedures. |
| Design | Substantially equivalent. The tubing is a 40 durometer tube with an inside diameter of 0.375" and an outside diameter of 0.562". |
| Technology/Principle of Operation | Substantially equivalent. Used as a conduit for fluids being removed from the body following bypass procedures, moved from the body, via vacuum, into a reservoir. |
| Materials | Differences in polyvinylchloride materials "raise no new issues of safety and effectiveness." Blood contacting materials were tested according to FDA General Program Memorandum #G95-1 and found to be biocompatible. |
| Performance | Substantially equivalent to the performance of the cleared Gish tubing. Achieves a Sterility Assurance Level (SAL) of 10 to the negative sixth (validated per AAMI guidelines). Ethylene oxide residuals will not exceed maximum residue limits. Expiration dating controlled by shortest expiry component or two years. |
| Safety and Effectiveness Issues | No new issues of safety or effectiveness raised. |
Study Proving Device Meets Acceptance Criteria:
The "study" here is not a typical clinical trial but rather a demonstration of substantial equivalence through comparison to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. There is no "test set" in the traditional sense of a clinical or analytical performance study with a specific number of samples. The demonstration of equivalence relies on comparing the device's characteristics and performance to those of a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. Ground truth, in the sense of expert consensus on diagnostic accuracy or clinical outcomes, is not established for this type of 510(k) submission. The "truth" is established by showing that the characteristics of the new device are sufficiently similar to a legally marketed predicate device.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method described as there isn't a test set requiring adjudication of findings.
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
Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is established by the known characteristics, safety, and effectiveness of the predicate device (Gish Biomedical Tubing, K870792). The new device is compared against this established benchmark.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not a machine learning device.
9. How the ground truth for the training set was established
Not applicable. 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).