(92 days)
The NovoSci™ NovoCoat™ treated tubing and connectors are indicated for use in cardiopulmonary surgical procedures requiring extracorporeal support for periods up to 6 hours.
The NovoSci ™ tubing and connectors treated with NovoCoat™ are sterile, single use only, disposable devices. They are used to connect cardiopulmonary bypass components used during surgery procedures requiring extracorporeal support. When used on devices for cardiopulmonary surgery, the NovoCoat™ treatment improves blood compatibility of non-biological surfaces in the extracorporeal circuit.
NovoSci™ tubing is polyvinyl chloride (PVC) tubing available in various sizes. The NovoSci™ connectors are polycarbonate in various configurations such as straight, reducing, "Y", with or without luer ports.
Acceptance Criteria and Study for NovoSci™ Tubing and Connectors with NovoCoat™
This 510(k) summary focuses on demonstrating that the NovoSci™ Tubing and Connectors with NovoCoat™ are substantially equivalent to the predicate device, NovoSci™ Duraflo treated tubing and connectors. The acceptance criteria and supporting study are therefore based on non-clinical performance and biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Reported Device Performance (NovoSci™ NovoCoat™) | Based on Equivalence to Predicate |
|---|---|---|
| Biocompatibility | Demonstrated equivalence | Yes |
| In-vitro | Demonstrated equivalence | Yes |
| Blood Damage | Demonstrated equivalence | Yes |
| Bond Strength | Demonstrated equivalence | Yes |
| Hardness | Demonstrated equivalence | Yes |
| Leak Test | Demonstrated equivalence | Yes |
| Pump Life | Demonstrated equivalence | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each non-clinical test. However, it indicates that "Non-clinical testing" was performed. Given the nature of medical device testing (especially for substantial equivalence), it is assumed that appropriate, statistically valid sample sizes were used for each test to demonstrate equivalence to the predicate device.
The data provenance is not explicitly stated in terms of country of origin. The study is a non-clinical, in-vitro, bench-top testing assessment, therefore the concept of "retrospective or prospective" doesn't directly apply in the same way as a clinical trial. The testing was conducted to support the 510(k) submission, suggesting it was purpose-designed (prospective) to gather data for regulatory review.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This section is not applicable to this 510(k) submission. The device is a medical accessory (tubing and connectors), and its performance assessment is based on objective, measurable physical and chemical properties through non-clinical testing rather than human interpretation of data where "ground truth" would be established by experts.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or clinical endpoints that require expert consensus, which is not the case for these non-clinical tests. The tests performed are objective measurements.
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 section is not applicable. This is a 510(k) submission for a physical medical device (tubing and connectors), not an AI-powered diagnostic or interpretive system. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. This submission is for a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the acceptance criteria in this submission is the established performance characteristics of the predicate device, NovoSci™ Duraflo treated tubing and connectors. The tests (biocompatibility, blood damage, bond strength, hardness, leak test, pump life) were designed to demonstrate that the new device performs equivalently to this well-established predicate. This would involve comparing quantitative or qualitative results of the new device against the known and accepted performance range/values of the predicate device.
8. The Sample Size for the Training Set
This section is not applicable as this is a non-AI medical device and does not involve a "training set" in the context of machine learning or algorithms.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reasons as point 8.
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.