(37 days)
The Small (4") and Large (6") Roller Pumps for the Terumo® Advanced Perfusion System 1 are indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
The Small (4") and Large (6") Roller Pumps of the Terumo® Advanced Perfusion System 1 (System 1) are peristalic pumps with 4 inch and 6 inch diameter raceways. The pumps can be mounted on the base of the System 1 console or can be positioned in an optimal location in the perfusion circuit by mounting to the system poles. Operation of the pumps can be configured using the System 1 Central Control Monitor (CCM). Local user interface displays and control panels are also located on the front of the large and small roller pumps. The small roller pump can accommodate applications requiring flow rates up to 4 L/min including pediatric arterial, adult and pediatric cardioplegia, vent and suction pumping, whereas the large roller pump can accommodate applications requiring flow rates up to 10 L/min including adult and pediatric arterial, cardioplegia, vent and suction pumping. The small and large roller pumps both have variable tube clamp mechanisms that accommodate a variety of tubing sizes, including dual tube sets.
This document, K162843, is a 510(k) premarket notification for updates to the Terumo Advanced Perfusion System 1 Roller Pumps. The main change described is the inclusion of medical grade silicone tubing as a compatible tubing option for both the Small (4") and Large (6") Roller Pumps. Since the device is substantially equivalent to a previously cleared predicate device (K153376), it primarily relies on demonstrating that the new tubing material does not adversely affect the device's safety and effectiveness.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding "reported device performance" values for all functionality. Instead, it leverages the substantial equivalence to a predicate device and focuses on confirming that the new medical grade silicone tubing does not compromise the established performance.
However, based on the Functional Summary and Flow Range Accuracy sections, we can infer some performance characteristics and the implicit "acceptance criteria" that the subject device (with silicone tubing) must meet by being "Identical to predicate device."
| Feature/Parameter | Acceptance Criteria (Implicit, based on predicate device K153376) | Reported Device Performance (with medical grade silicone tubing) |
|---|---|---|
| Small Roller Pump | ||
| Max Flow Rate | up to 4 L/min | Met: Small roller pump can accommodate applications requiring flow rates up to 4 L/min |
| Tubing Compatibility | Medical Grade PVC 9/16" OD (max) 1/16" – 3/32" wall thickness | Met: Also compatible with Medical Grade Silicone 9/16" OD (max) 1/16" – 3/32" wall thickness |
| Flow Range Accuracy (0.0-1.0 L/min) | ± 10% of actual | Met: Identical to predicate device |
| Flow Range Accuracy (1.0-4.0 L/min) | ± 8% of actual | Met: Identical to predicate device |
| Large Roller Pump | ||
| Max Flow Rate | up to 10 L/min | Met: Large roller pump can accommodate applications requiring flow rates up to 10 L/min |
| Tubing Compatibility | Medical Grade PVC 11/16" OD (max) 1/16" – 3/32" wall thickness | Met: Also compatible with Medical Grade Silicone 11/16" OD (max) 1/16" – 3/32" wall thickness |
| Flow Range Accuracy (0.0-1.0 L/min) | ± 10% of actual | Met: Identical to predicate device |
| Flow Range Accuracy (1.0-10.0 L/min) | ± 8% of actual | Met: Identical to predicate device |
| Speed Range / Accuracy | 0 - 250 RPM ± 2 RPM or 1% of actual | Met: Identical to predicate device |
| Other Functional Characteristics | Identical to predicate device (e.g., Panel Displays & Controls, Pump Configurations/Modes, Internal Monitoring, Controls & Safety) | Met: Performance testing confirmed design input requirements met. |
The "Reported Device Performance" column essentially states "met" or "identical to predicate device" because the core of this 510(k) is to demonstrate that the addition of silicone tubing compatibility maintains the performance characteristics of the already cleared predicate device. The conclusion explicitly states: "Performance testing has confirmed that the design input requirements were met demonstrating that medical grade silicone tubing can be used with the Small and Large System 1 Roller Pumps."
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Performance testing of medical grade silicone tubing with the Small and Large System 1 Roller Pumps has been completed successfully." However, it does not specify the sample size (e.g., number of pumps, number of tests, duration of tests) used for this performance testing.
Regarding data provenance, the document does not explicitly state the country of origin or if the study was retrospective or prospective. It implies the testing was conducted by Terumo Cardiovascular Systems Corporation as part of their 510(k) submission, suggesting it was likely prospective testing specifically for this change.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of human experts to establish ground truth for performance testing in the context of device function for roller pumps. Performance criteria for such devices (flow rate accuracy, speed accuracy, tubing compatibility, etc.) are typically established through engineering specifications and objective measurements, not subjective expert assessment. Therefore, this question is not directly applicable to the type of device and testing described.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method. As noted above, the performance testing for this device is based on objective measurements against engineering specifications, not on subjective assessments that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done for this device. This type of study is typically used for diagnostic devices where human interpretation of images or data is involved, and the goal is to evaluate the effectiveness of AI assistance on human reader performance. The Terumo roller pumps are mechanical devices, and their performance is evaluated through objective measurements and engineering tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the term "standalone" typically refers to AI algorithm performance without human intervention, in the context of this mechanical device, the "performance testing" described can be considered analogous to "standalone" in that it evaluates the device's function (with the new tubing) based on its intrinsic capabilities against predefined criteria, without an explicit "human-in-the-loop" interaction as part of the primary performance assessment. The device is designed to operate mechanically, and the performance tests verify its mechanical and fluid dynamics properties.
7. The Type of Ground Truth Used
The ground truth used for this device's performance testing consists of:
- Engineering Specifications: Predefined quantitative thresholds for parameters like flow rate accuracy, speed accuracy, and dimensions.
- Functional Equivalence: The expectation that the subject device, with the new tubing, performs identically or equivalently to the predicate device in terms of all functional aspects (e.g., pump configurations, controls, safety).
- Biocompatibility (implied): The "medical grade silicone tubing" implies that material properties and safety (e.g., non-toxicity, durability) were assessed, although specific details are not provided in this summary.
8. The Sample Size for the Training Set
The concept of a "training set" is relevant to machine learning/AI devices. Since the Terumo roller pump is a mechanical device, there is no training set in the AI/ML sense. Its design and performance are based on engineering principles and physical testing, not data-driven learning.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this mechanical device, this question is not applicable.
§ 870.4370 Roller-type cardiopulmonary bypass blood pump.
(a)
Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.(b)
Classification. Class II (performance standards).