(85 days)
The Capiox Circuit Connectors are intended to be used to interconnect tubing and other devices in an extra-corporeal circuit during cardiopulmonary bypass procedures. The devices can be used in procedures lasting up to 6 hours in duration.
The connectors that are the subject of this premarket notification are of various designs (quickconnection and rotary-style) - each of which provides for the flow of blood and extra-corporeal fluids through the bypass circuit. Each of the connectors is made from polycarbonate and includes a silicone rubber O-ring for seal maintenance. Similarly, the predicate connectors are also quick-connect style connectors and include a silicone rubber O-ring for seal maintenance.
The provided text describes a 510(k) premarket notification for the Terumo Capiox® Circuit Connectors. This is a medical device for use in cardiopulmonary bypass procedures, and the submission aims to demonstrate its substantial equivalence to a previously cleared predicate device.
Here's an analysis of the acceptance criteria and the study details based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| 6-Hour Circulation Test (Comparative vs. predicate device) | Exhibited performance deemed substantially equivalent to predicate devices. |
| Dimensional Analysis (Attribute Evaluation / Not compared to predicate) | Differences in physical dimensions exist, but "do not impact performance or patient safety." |
| Structural Integrity / Leakage Testing (Attribute Evaluation / Not compared to predicate) | Exhibited performance deemed substantially equivalent to predicate devices. |
| Tubing Connection Strength (Attribute Evaluation / Not compared to predicate) | Exhibited performance deemed substantially equivalent to predicate devices. |
| Sterilization conditions validated according to AAMI guidelines | Validated to provide a Sterility Assurance Level (SAL) of 10⁻⁶. |
| Biocompatibility of blood-contacting materials (based on G95-1) | Blood-contacting materials considered biocompatible. |
| Safety of polymer coating (X-Coating™) (for previous devices) | Evaluated in an in-vivo animal study; no adverse conditions noted. The coating "does not introduce any new issues of safety or product effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each in-vitro test (6-Hour Circulation, Dimensional Analysis, Structural Integrity/Leakage, Tubing Connection Strength). It only states that these are "in-vitro performance evaluations."
Regarding data provenance:
- The tests are described as "in-vitro performance evaluations," meaning they were conducted in a laboratory setting.
- Clinical studies involving patients were explicitly stated as not necessary.
- The manufacturer is Terumo Corporation (Ashitaka Factory) in Shizuoka Pref., Japan. The submission was prepared by Terumo Corporation/Terumo Cardiovascular in Elkton, MD, USA. This suggests the data collection and analysis were likely performed by the manufacturer, potentially in Japan or the US, but the specific location of the test set data generation is not detailed beyond being "in-vitro."
- All test results are reported retrospectively for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This submission focuses on in-vitro performance evaluations of a physical medical device, not on interpreting diagnostic images or clinical data where human expert consensus would typically establish ground truth. The "ground truth" for these tests would be the measured physical properties and performance characteristics against established engineering and safety standards, or against the predicate device's performance.
4. Adjudication Method for the Test Set
- Not applicable. As there are no human-interpreted diagnostic findings or clinical outcomes requiring consensus, an adjudication method for a test set is not relevant in this context. The performance evaluations are objective, quantifiable measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC comparative effectiveness study was not done. The device in question is a circuit connector for cardiopulmonary bypass; it is a physical component, not a diagnostic or AI-driven system that would involve human readers interpreting cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical connector, not an algorithm. Therefore, a standalone performance study in the context of AI or software performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluations are:
- Predicate Device Performance: For the 6-Hour Circulation Test, the performance of the proposed device was compared to the predicate device to establish substantial equivalence.
- Engineering Specifications/Standards: For Dimensional Analysis, Structural Integrity/Leakage Testing, and Tubing Connection Strength, the ground truth would be the defined acceptable ranges or thresholds based on engineering specifications, manufacturing tolerances, and safety standards for medical device components.
- AAMI Guidelines (SAL of 10⁻⁶): For sterilization validation.
- FDA General Program Memorandum #G95-1 / ISO 10993: For biocompatibility and material safety.
- Previous In-vivo Animal Study: For the safety of the X-Coating™.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI or machine learning device requiring a "training set." The device is a physical product, and its design and manufacturing would rely on established engineering principles and material science, not statistical training data in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth for it.
§ 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.