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510(k) Data Aggregation
(59 days)
Terumo Pump Tubing
The Terumo® Pump Tubing is intended to provide a conduit for extracorporeal fluid flow through a roller pump during cardiopulmonary bypass procedures. The tubing is intended for use in procedures lasting up to 6-hours in duration.
The Terumo® Pump Tubing is comprised of a commonly used polyvinyl chloride resin (PVC) that includes a plasticizer recognized as Di-(2-ethylhexyhl) phthalate (DEHP). The PVC tubing that is the subject of this application is 68 durometer pump tubing (Shore A Hardness nominal measurement). It has a nominal inside diameter of 3/32" and a nominal wall thickness of 1/16". The outside diameter measures 7/32" (nominal). The 68D PVC Pump Tubing will have a Shore A nominal durometer of 68D while the predicate device, the 70D PVC Pump Tubing, has a Shore A nominal durometer of 70D. The durometer dictates the hardness of the tubing. There are no internal markings on the subject tubing. Outside markings consist of the Terumo symbol, followed by inner diameter (in inches) x wall thickness (in inches), durometer, and TCVS part number.
The acceptance criteria and the study that proves the device meets the acceptance criteria are not explicitly detailed in the provided text in the typical format of a device's performance metrics against predefined thresholds. This document is a 510(k) premarket notification letter, which focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a performance study with detailed acceptance criteria for a new, novel device.
However, based on the information provided, we can infer the acceptance criteria and the nature of the study conducted to demonstrate equivalence for the Terumo® Pump Tubing (68D PVC Pump Tubing) to its predicate (70D PVC Pump Tubing).
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a table of quantitative acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it lists the performance evaluations conducted to demonstrate "functional equivalence" to the predicate device. The implied acceptance criterion for each test is that the 68D PVC Pump Tubing performs equivalently to or within acceptable limits of the 70D PVC Pump Tubing, without raising new issues of safety or effectiveness.
| Performance Evaluation Type | Implied Acceptance Criteria (based on "functional equivalence") | Reported Device Performance (Summary from text) |
|---|---|---|
| Visual Analysis | No significant manufacturing defects or visual differences that impact safety/effectiveness compared to predicate. | Not explicitly detailed, but implied to be equivalent/acceptable. |
| Connection Strength | Connection strength equivalent to predicate, ensuring secure connections during use. | Not explicitly detailed, but implied to be equivalent/acceptable. |
| Connection Leak Testing | No leaks when connected, equivalent to predicate, ensuring integrity of the fluid path. | Not explicitly detailed, but implied to be equivalent/acceptable. |
| Roller Pump Performance (Durability) | Durability under roller pump operation for up to 6 hours, equivalent to predicate, without material degradation or failure. | Not explicitly detailed, but implied to be equivalent/acceptable. |
| Dimensional Analysis | Dimensions (ID, wall thickness, OD, durometer) within acceptable manufacturing tolerances and deemed functionally equivalent to predicate despite nominal durometer difference. | 68D (nominal) durometer, 3/32" nominal ID, 1/16" nominal wall thickness, 7/32" nominal OD. Assessed to be functionally equivalent to 70D predicate. |
| Spallation | Minimal to no particulate generation during operation, equivalent to predicate, to prevent harmful emboli. | Not explicitly detailed, but implied to be equivalent/acceptable. |
| Packaging Integrity Evaluation | Packaging maintains sterility and physical integrity up to point of use. | Not explicitly detailed, but implied to be equivalent/acceptable. |
| Shelf Life Evaluation | Device maintains functional requirements, safety, and sterility over proposed shelf life. | Not explicitly detailed, but implied to be equivalent/acceptable. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample sizes used for each of the performance evaluations (e.g., number of tubing samples tested for durability, connection strength, etc.).
- Data Provenance: The studies were conducted by Terumo Cardiovascular Systems Corporation as "in-vitro performance evaluations." The country of origin of the data is implied to be within the US, where Terumo Cardiovascular Systems Corporation is located (Elkton, MD and Ashland, MA). The studies are "premarket notification" tests, which are inherently prospective for the purpose of this submission (i.e., conducted specifically to support this 510(k)).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device and study. The testing described (e.g., dimensional analysis, connection strength, durability) relies on objective physical and chemical measurements rather than expert interpretation of complex data (like medical images). Therefore, "ground truth" in the traditional sense of expert consensus (e.g., for diagnostic accuracy) is not established.
4. Adjudication Method for the Test Set
Not applicable. As described above, the tests are objective physical/chemical measurements, not requiring expert adjudication in the manner of medical imaging or clinical trial outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human readers interpret patient data (e.g., images), and the AI's impact on reader performance is measured. The Terumo Pump Tubing is a component for cardiopulmonary bypass and does not involve human readers interpreting "cases."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. "Standalone performance" refers to the accuracy of an AI algorithm operating independently. The Terumo Pump Tubing is a physical medical device, not an algorithm. The performance evaluations conducted are intrinsic to the device's physical and mechanical properties.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluations (e.g., connection strength, durability, dimensions) is established by the specifications and performance characteristics of the predicate device (70D PVC Pump Tubing), as well as relevant industry standards and internal quality control specifications for medical devices of this type. The objective is to demonstrate that the new device's performance aligns with these established benchmarks, ensuring it is at least as safe and effective as the legally marketed predicate.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI algorithm, and therefore does not have a "training set" in the machine learning context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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