(42 days)
The CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device, which is intended to be used with the CORx System in surgical procedures requiring extracorporeal hemodynamic and gas exchange support. The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute and lasting for up to six hours.
The CardioVention PowerBase™ Console is a cardiopulmonary bypass flow control device.
The provided text is a 510(k) Summary for the CardioVention PowerBase™ Console. This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a detailed study with specific acceptance criteria and performance metrics typically found in clinical trials for AI/software devices. Therefore, much of the requested information is not explicitly available in this type of regulatory submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Safety and Effectiveness: CardioVention PowerBase™ Console is safe and effective for its intended function. | Results of in-vitro and software testing demonstrate that CardioVention PowerBase™ Console is safe and effective for its intended function. Substantial equivalence to the currently marketed and unmodified predicate device (CardioVention PowerBase™ Console [K021694] and the CardioVention CORx System [K012325]) for its intended use, product performance, and software. |
| Intended Use Parameters: Used with CORx System in surgical procedures requiring extracorporeal hemodynamic and gas exchange support. | The device is described as a cardiopulmonary bypass flow control device intended for the stated use. |
| Maximum Blood Flow Rate: Six liters/minute. | The device is indicated for use in procedures requiring a maximum blood flow rate of six liters/minute. |
| Procedure Duration: Up to six hours. | The device is indicated for use in procedures lasting for up to six hours. |
2. Sample Size Used for the Test Set and the Data Provenance
The document states "Results of in-vitro and software testing," but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This is common for submissions focused on substantial equivalence of hardware and software components, where bench testing and verification are emphasized over clinical trial-like data for initial market clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. Given the nature of the device (a cardiopulmonary bypass console) and the testing described (in-vitro and software), it's more likely that performance was verified against engineering specifications and industry standards rather than a "ground truth" established by medical experts in the way one would for diagnostic imaging.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or indicated. This type of study is typically performed for diagnostic or AI-assisted interpretation devices to compare human performance with and without AI assistance. The CardioVention PowerBase™ Console is a control device, not an interpretive one.
6. Standalone Performance Study
The document states "Results of in-vitro and software testing demonstrate that CardioVention PowerBase™ Console is safe and effective for its intended function." This implies a form of standalone testing of the device's functionality and safety, but it is not a "standalone (i.e., algorithm only without human-in-the-loop performance)" in the context of an AI algorithm's diagnostic accuracy. It refers to the device's operational performance independent of human error in its direct use.
7. Type of Ground Truth Used
The "ground truth" for this type of device would likely be based on engineering specifications, established physiological parameters for cardiopulmonary bypass, and recognized industry standards for safety and performance of such medical devices. The document does not specify "pathology" or "outcomes data" as ground truth.
8. Sample Size for the Training Set
This information is not provided. Given that this is a 510(k) for a cardiopulmonary bypass console cleared in 2003, it predates the widespread use of deep learning and large-scale AI models requiring extensive "training sets" in the modern sense. The "software testing" likely refers to traditional software verification and validation, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
As there's no mention of a "training set" in the context of machine learning, this information is not applicable/provided. If "training set" refers to data used to develop the software, it would be internal development data validated against engineering requirements, but no details are given.
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).