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510(k) Data Aggregation
(28 days)
THE ZIP is an accessory to the PleuraFlow® System with FlowGlide®. It is indicated for use during cardiothoracic surgical procedures and chest trauma. Its Active Clearance Technology® proactively removes clots formed inside the chest tube to prevent or minimize chest tube occlusion with clot. A patent chest tube enables evacuation of blood and fluid from the operative site after closure of the surgical wound and reduces retained blood. The product is indicated for adult and pediatric patients including infant, preadolescent patients under clinical settings.
THE ZIP accessory is a non-sterile reusable external, hand-held free-standing magnetic shuttle that is used to couple and move the Clearance Wire of the PleuraFlow System. It can be used instead of the PleuraFlow System's integral Shuttle when the user determines that increase of magnetic coupling is needed to break up and clear any tube obstructions or clogging to keep the tube patent.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Decoupling Force | Results from performance testing demonstrate suitability for intended use and do not raise new issues of safety and effectiveness when compared to the predicate device (PleuraFlow System with FlowGlide®). The exact numerical criterion and result are not provided in the summary. |
| Magnetic Flux | Results from performance testing demonstrate suitability for intended use and do not raise new issues of safety and effectiveness when compared to the predicate device. The exact numerical criterion and result are not provided in the summary. |
| Functionality | Performance testing confirmed functionality, demonstrating suitability for intended use and no new safety or effectiveness issues compared to the predicate. Specific functional parameters and outcomes are not detailed. |
| Drop | Drop testing confirmed device robustness, demonstrating suitability for intended use and no new safety or effectiveness issues compared to the predicate. Specific drop test parameters (e.g., height, number of drops) and outcomes are not detailed. |
| Indications For Use | THE ZIP's Indications For Use are the same as the predicate (PleuraFlow System with FlowGlide®). This implies that the device is expected to perform equivalently in its intended clinical applications: proactively removing clots, preventing or minimizing chest tube occlusion, and enabling evacuation of blood and fluid during cardiothoracic surgical procedures and chest trauma. This is a qualitative rather than a quantitative performance metric. |
| Technological Characteristics | Technological characteristics of THE ZIP are similar to the predicate. This suggests design and operational principles are comparable, leading to similar performance and safety profiles. This is a qualitative comparison rather than a quantitative performance metric. |
| Risk-Benefit Analysis | The risk-benefit analysis, verification and validation, and biocompatibility of THE ZIP do not raise any additional concerns regarding safety and effectiveness compared to the predicate. This is a qualitative assessment rather than a quantitative performance metric. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document describes bench testing for THE ZIP accessory. Therefore, there are no "test set" or "data provenance" in the clinical sense (e.g., patient data, country of origin, retrospective/prospective). The "sample size" would refer to the number of individual devices or components tested for each specific bench test. However, the document does not specify the exact number of units tested for Decoupling Force, Magnetic Flux, Functionality, or Drop tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This was a bench testing study, not a study involving human interpretation of medical data. Therefore, no experts were used to establish ground truth in this context.
4. Adjudication Method for the Test Set:
Not applicable. As this was a bench testing study, there was no need for adjudication of expert opinions. The performance metrics were directly measured from the device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. THE ZIP is a mechanical accessory to a medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. THE ZIP is a mechanical device, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance was established through direct physical measurement and observation during bench testing against predefined engineering specifications and functional requirements. These requirements were based on the performance of the legally marketed predicate device (PleuraFlow System with FlowGlide®) which served as the benchmark for substantial equivalence.
8. The Sample Size for the Training Set:
Not applicable. This is a mechanical device, not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, for the same reason as above; there is no training set for a mechanical device.
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