(28 days)
This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass surgery procedures.
Tubing, Connectors, and Accessories with Balance™ Biosurface are used in cardiopulmonary bypass for connecting the primary devices of the bypass circuit. The functionality and intended use of these devices are the same as those for the coated (Trillium® Biosurface) and uncoated tubing, connectors, and accessories that are FDA cleared. Balance™ Biosurface has been previously FDA cleared (K100646) and is commercially available. Balance™ Biosurface is a non-leaching biocompatible surface that reduces platelet adhesion and activation and preserves platelet function.
The manufacturer of the "Tubing, Connectors, and Accessories with Balance™ Biosurface" conducted a study to demonstrate its substantial equivalence to predicate devices. The study focused on assessing the device's performance across various parameters relevant to its intended use in cardiopulmonary bypass.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test were implied by a "Pass" result, indicating the device met the required performance standards for substantial equivalence.
| Verification/Validation | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Balance™ Biosurface coverage | Met coverage requirements | Pass |
| Balance™ Biosurface leaching | Met non-leaching requirements | Pass |
| Hemolysis | Met hemolysis limits | Pass |
| White Blood Cell (WBC) Retention | Met WBC retention limits | Pass |
| Platelets Retention/Platelet Activation | Met platelet performance | Pass |
| Kallikrein Generation | Met kallikrein limits | Pass |
| Tubing kink resistance | Met kink resistance | Pass |
| Pressure integrity | Maintained pressure integrity | Pass |
| Pressure decay | Met pressure decay limits | Pass |
| Tubing pull force | Met pull force requirements | Pass |
| No tubing pull off during static force | Maintained secure connection | Pass |
| Tubing Life | Met tubing life requirements | Pass |
| Tubing Spallation | Met spallation limits | Pass |
| Biocompatibility Assessment | No impact to biocompatibility | Pass |
| Packaging and Sterilization Assessment | No impact to P&S | Pass |
| Shelf-Life Verification | Met shelf-life requirements | Pass |
2. Sample Size and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test. The data provenance is internal to Medtronic, Inc., a U.S.-based company, and the tests were likely conducted prospectively as part of the device's design verification and validation process prior to 510(k) submission. No information about country of origin of the data is provided beyond the submitting company's location.
3. Number of Experts and Qualifications for Ground Truth
This type of submission for tubing and connectors does not typically involve human expert consensus for "ground truth" in the way a diagnostic imaging device would. The ground truth for these performance tests is based on established engineering and biocompatibility standards and test methods. Therefore, the concept of "number of experts" for ground truth establishment, in this context, is not applicable. The expertise would lie in the engineers and scientists who designed the tests and interpreted the results against defined criteria.
4. Adjudication Method
Adjudication methods like 2+1 or 3+1 are used for studies involving subjective human interpretation (e.g., image analysis). For the objective performance tests listed in this submission, an adjudication method is not applicable. The results are quantitative (e.g., measurements, counts) or qualitative (e.g., visual inspection) against predefined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic devices where human readers interpret medical images or data, and the effect of AI on their performance is evaluated. This device (tubing and connectors) is a component of a medical system and does not involve human interpretation in a diagnostic context that would necessitate such a study.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. The device is a physical medical component, not an algorithm. Therefore, the concept of an "algorithm only" performance study is not applicable. The performance studies assessed the physical and biological characteristics of the device itself.
7. Type of Ground Truth Used
The "ground truth" for the performance tests was based on:
- Engineering Specifications and Standards: For physical tests like kink resistance, pressure integrity, pull force, and tubing life.
- Biocompatibility Standards: For tests related to biological interactions such as hemolysis, WBC retention, platelet retention/activation, kallikrein generation, and biocompatibility assessment.
- Material Science Principles: For tests like Biosurface coverage and leaching.
8. Sample Size for the Training Set
This product is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of machine learning model development. The tests performed are verification and validation tests for the physical product.
9. How Ground Truth for the Training Set Was Established
As there is no training set for an AI or machine learning model, this question is not applicable.
§ 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.