(85 days)
The Pump Tubing is intended to provide a conduit for extracorporeal blood flow through a roller pump during cardiopulmonary bypass procedures. The tubing is also intended to provide a conduit for extracorporeal blood flow when interconnecting components of the bypass circuit.
The tubing is intended for use in procedures lasting up to 6-hours in duration.
Each of the three sizes of the Pump Tubing that is included in this submission is Each of the tires child of the (PVC). The tubing ranges in size from a ¼" inside diameter to ½" in diameter. The durometer measurement is Shore A-68.
Acceptance Criteria and Device Performance Study
This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the Plastron Pump Tubing to its predicate device, Pexco PVC pump tubing. The provided text is a 510(k) summary, which focuses on demonstrating equivalence rather than establishing novel performance metrics or conducting a comprehensive clinical study.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Plastron Pump Tubing were based on demonstrating equivalence to the predicate Pexco PVC pump tubing across several performance categories. The "acceptance criteria" here implicitly means that the Plastron tubing's performance in these areas should not be "clinically significantly different" from the predicate.
| Performance Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Dimensional Analysis | Dimensions (e.g., ID, wall thickness, durometer) are equivalent to predicate. | The tubing ranges in size from a ¼" inside diameter to ½" in diameter. The durometer measurement is Shore A-68. (Implied to be equivalent to predicate in these aspects). |
| Leakage Testing/Structural Integrity | No leaks or structural failures under simulated use conditions, equivalent to predicate. | Tests were conducted to demonstrate equivalence. |
| Effects Upon Cellular Components (Hemolysis) | Hemolysis levels are clinically acceptable and equivalent to predicate. | Tests were conducted to demonstrate equivalence. |
| Flow Rate Testing | Flow rates under various pump conditions are equivalent to predicate. | Tests were conducted to demonstrate equivalence. |
| Durability Testing | Ability to withstand cyclically compressed forces for procedures up to 6 hours, equivalent to predicate. | Tests were conducted to demonstrate equivalence. |
| Spallation Evaluation | Minimal particulate generation, equivalent to predicate. | Tests were conducted to demonstrate equivalence. |
| Thrombus Formation (Visual) | Minimal visually identifiable thrombus formation, equivalent to predicate. | Tests were conducted to demonstrate equivalence. |
| Sterilization Conditions | Sterility Assurance Level (SAL) of 10⁻⁶. | Validated in accordance with AAMI guidelines to provide a SAL of 10⁻⁶. |
| Ethylene Oxide Residues | Not to exceed maximum residue limits. | Will not exceed maximum residue limits proposed for Part 821 of Title 21 of the Federal Register of June 23, 1978. |
| Biocompatibility | Found to be biocompatible for circulating blood, limited exposure (≤ 24 hours). | Conducted studies recommended in FDA GPM #G95-1 (ISO 10993) and found blood contacting materials to be biocompatible. |
Summary of Performance: The document explicitly states: "The comparisons demonstrated that there were no clinically significant performance differences between the two devices."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each individual test (Dimensional Analysis, Leakage, Hemolysis, etc.). It only mentions that "The following tests were conducted to demonstrate equivalence in performance."
- Data Provenance: The origin of the data is not explicitly stated in terms of country or specific institution. Given the context of a 510(k) summary submitted to the FDA by Olson Medical Sales, Inc. (Ashland, MA), it is highly likely that the testing was conducted in the United States or by accredited laboratories adhering to US standards. The study appears to be retrospective in the sense that existing predicate device performance (which presumably has a history of safe use) is used as a benchmark for the new device. The testing of the Plastron Pump Tubing itself would have been prospective to demonstrate its equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This document describes an engineering and materials equivalence study, not a study requiring expert clinical interpretation to establish ground truth in the traditional sense. Therefore:
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
The "ground truth" for this type of submission is largely defined by the established performance and safety record of the predicate device and the objective results from standardized engineering and biocompatibility tests.
4. Adjudication Method
Not applicable, as this was not a study requiring human interpretation or adjudication for establishing ground truth. The tests conducted are objective measurements (e.g., dimensions, flow rates, chemical residues) or standardized evaluations (e.g., hemolysis, biocompatibility per ISO 10993).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance is evaluated. This submission is for medical tubing, which does not involve human interpretation in this manner.
6. Standalone Performance Study
Yes, implicitly, a standalone performance study of the Plastron Pump Tubing was performed. The "Performance Evaluations" section lists several tests (Dimensional Analysis, Leakage Testing, Hemolysis, Flow Rate, Durability, Spallation, Thrombus Formation) conducted on the Plastron Pump Tubing. The results of these tests were then compared to the performance of the predicate Pexco PVC pump tubing to establish substantial equivalence.
7. Type of Ground Truth Used
The ground truth used for this equivalence study primarily relies on:
- Predicate Device Performance: The established, legally marketed performance and safety profile of the Pexco PVC tubing serves as the primary "ground truth" for comparison.
- Engineering Standards and Specifications: Objective measurements and adherence to specified ranges (e.g., durometer Shore A-68, ID ¼" to ½").
- Biocompatibility Standards: Adherence to recognized international standards like ISO 10993 (e.g., "blood contacting materials were found to be biocompatible").
- Sterilization Standards: Validated in accordance with AAMI guidelines for SAL.
- Regulatory Limits: Compliance with FDA regulations for Ethylene Oxide residues.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set." The device is a physical medical component, and the testing involves laboratory evaluation, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 870.4390 Cardiopulmonary bypass pump tubing.
(a)
Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).