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510(k) Data Aggregation
(537 days)
The Better-Tubing™ is designed for use as a blood compatible conduit for pumping blood in a roller pump during cardiopulmonary bypass or other extracorporeal applications of up to 6 hours.
The Better-Tubing™ (BT) is a 6 ft. length of ¼' ID tubing for use in an extracorporeal cardiopulmonary bypass circuit. It is biocompatible, has high tensile strength, and has many advantages over standard tubing made from polyvinyl chloride (PVC).
Here's a breakdown of the acceptance criteria and study information for the Better-Tubing™ device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Claim | Better-Tubing™ Reported Performance |
|---|---|
| Biocompatibility | Passed all ISO 10993 Part-1 Biocompatibility Tests (Intracutaneous Toxicity, Cytotoxicity, Sensitization, Systemic Toxicity, Genotoxicity, Implantation with Histopathology, Hemolysis, Whole Blood Coagulation Time, Pyrogenicity) |
| Effect of Temperature on Flow | Minimally affected by fluid temperature. Flow differed by no more than 3% at 22±2°C and 37±2°C. |
| Hemolysis (compared to Tygon® tubing) | Significantly less hemolytic than Tygon® tubing with standard occlusion (p<0.0046). No significant difference from Tygon® tubing set nonocclusively. IH (% STD-SO) of 30% ± 4% (BT-SO) and 35% ± 9% (BT-NO) vs. 100% (TY-SO). |
| Pressure Resistance | Able to withstand 2500 mmHg (50 psi) for 60 min without leaks or bursting. Pressure decreased only 2% over 60 min. |
| Tensile Strength (compared to predicate tubing) | 3 to 6 times greater than the predicate tubing. |
| Pumping Life (compared to standard tubing) | Equal to or greater than standard tubing. Decreases in flow after 6 hours were the same as Super-Tygon®. |
| Abrasion Resistance / Spallation | High abrasion resistance and thus lower spallation. |
| Material Formulation | Differs from Tygon® in its material formulation. (Implicit acceptance: new material meets performance) |
| Intended Use (Blood compatible conduit for pumping blood in a roller pump during cardiopulmonary bypass or other extracorporeal applications of up to 6 hours.) | Met, as determined by the FDA's substantial equivalence finding. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Effect of Temperature on Flow: 3 BT tubes were tested.
- Hemolysis Tests:
- Number of circuits: Four identical circuits were tested simultaneously.
- Tubing samples: Four tubings (Tygon-SO, Tygon-NO, Better-Tubing-SO, Better-Tubing-NO) were tested. This implies 'n=4' for each group as shown in Table 3.
- Blood source: Fresh heparinized bovine blood obtained from a slaughterhouse.
- Pressure Tests: A 6 ft. length of Better-Tubing™ was tested.
Data Provenance: The studies appear to be primarily prospective, in-vitro (laboratory) tests conducted by the manufacturer, Circulatory Technology Inc. The blood for hemolysis tests was bovine and obtained from a slaughterhouse. The general provenance is implied to be within the US, corresponding to the FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a component (tubing) and the reported studies are performance tests (e.g., flow, pressure, hemolysis) against established benchmarks and predicate devices, not diagnostic assessments requiring expert interpretation of clinical images or data. Ground truth for these tests is based on objective measurements and established scientific protocols (e.g., ISO standards, spectrophotometric assays for hemolysis).
4. Adjudication Method for the Test Set
Not applicable. The reported studies are objective performance tests, not studies requiring expert adjudication of qualitative outcomes.
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 a medical device (tubing), not an AI/software device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device (tubing), not an algorithm. The reported tests are standalone performance tests of the tubing itself.
7. The Type of Ground Truth Used
The ground truth used for these studies is based on:
- Objective Measurements: Flow rates (ml/min), pressure (mmHg), temperature (°C), time (min), percentage changes.
- Established Test Standards: ISO 10993 Part-1 for biocompatibility.
- Reference Devices/Materials: Comparison against Tygon® tubing (predicate device) and Super-Tygon® for pumping life.
- Biochemical/Physical Assays: Spectrophotometric assay for plasma free hemoglobin to quantify hemolysis.
8. The Sample Size for the Training Set
Not applicable directly. This is a physical medical device. "Training set" typically refers to data used to train AI/machine learning models. For a physical device like this tubing, the "development" or "optimization" process would involve materials science, engineering, and manufacturing trials, which are not outlined in terms of a formal "training set" like in AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as explained in point 8. The "ground truth" for the development of such tubing would be the desired performance specifications (e.g., target tensile strength, desired flow characteristics, acceptable hemolysis levels) that the engineers aimed to achieve through material selection and design. These specifications would be derived from clinical needs, existing standards, and competitor analysis.
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