(231 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 describes a 510(k) premarket notification for the "CardioVention PowerBase™ Console," a cardiopulmonary bypass flow control device. However, it does not contain details about specific acceptance criteria, device performance metrics, or a formal study proving the device meets acceptance criteria in the way one would expect for an AI algorithm performance study.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through functional acceptance testing, ship testing, and software verification and validation. This is a common regulatory pathway for medical devices where the equivalence in indications for use, operational characteristics, and technological characteristics is the primary means of demonstrating safety and effectiveness.
Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document states that "Testing submitted in this premarket notification consists of functional acceptance testing, ship testing, and software verification and validation." However, it does not explicitly list the quantitative acceptance criteria for these tests or specific reported performance metrics beyond the intended use parameters.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly stated, inferred from intended use/equivalence) | Reported Device Performance (Not explicitly stated, "Substantially Equivalent" declared) |
|---|---|---|
| Functional Performance | Ability to control cardiopulmonary bypass flow. | Demonstrated sufficient control to achieve substantial equivalence. |
| Maximum Blood Flow Rate | Support procedures requiring up to 6 liters/minute. | Meets intended use: capable of 6 liters/minute. |
| Procedure Duration | Support procedures lasting up to 6 hours. | Meets intended use: capable of supporting procedures up to 6 hours. |
| Ship Testing | Withstand shipping and handling conditions without compromising function. | Passed ship testing, implying device integrity and functionality post-transport. |
| Software V&V | Software performs as intended, free from critical bugs. | Software verified and validated, implying reliable operation. |
| Equivalence | Operational and technological characteristics equivalent to predicate devices (K936091, K011838, K991864). | Declared substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The testing described (functional, ship, software V&V) typically involves internal product testing rather than a "test set" of clinical cases or data in the context of an AI algorithm.
- Data Provenance: Not applicable in the context of clinical data. The performance testing is internal to the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for a mechanical device like this is its physical and software functionality against engineering specifications, not expert consensus on medical images or diagnoses.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Mechanical and software testing typically involves direct measurement and verification against specifications, rather than adjudicating conflicting interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This is a device for controlling cardiopulmonary bypass flow, not an AI diagnostic or assistive imaging tool that would typically undergo an MRMC study.
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done: Yes, in an indirect sense. The "functional acceptance testing, ship testing, and software verification and validation" represent the device's standalone performance against its specifications and intended function. There is no "human-in-the-loop" concept in the performance evaluation described for this type of device, as it is a control system.
7. Type of Ground Truth Used
- Type of Ground Truth: Engineering specifications, functional requirements, and safety standards for cardiopulmonary bypass equipment. The device's performance is measured against these established technical benchmarks.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a traditional electro-mechanical medical device with embedded software, not a machine learning or AI-driven system that requires a "training set" of data in the common understanding. The software development process would involve various stages of testing and refinement, but not a "training set" for model learning.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no "training set" in the context of a machine learning algorithm. The software's "ground truth" is its design specifications and validated functionality.
§ 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).