(78 days)
Intended for the removal of blood from the pulmonary artery and decompression of the heart during endovascular cardiopulmonary bypass.
Not Found
This document describes a medical device called the "Endopulmonary Vent," a pulmonary vent catheter intended for removing blood from the pulmonary artery and decompressing the heart during endovascular cardiopulmonary bypass. The information provided is a 510(k) summary of safety and effectiveness, meaning it's a submission to the FDA (Food and Drug Administration) to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Here's an analysis of the provided text in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table of acceptance criteria or detailed device performance metrics. Instead, it states:
| Criterion Type | Details |
|---|---|
| Performance Standard | The device "will meet or exceed Heartport's performance standards." |
| Confidence Level | Demonstrated with "95% confidence." |
| Overall Conclusion | "Performance testing has demonstrated that the Endopulmonary Vent will function safely and effectively, while meeting the anticipated clinical requirements for the intended use." |
Critique: This summary is very high-level and lacks specific quantifiable acceptance criteria (e.g., flow rate thresholds, pressure limits, material biocompatibility metrics, etc.) and corresponding measured performance values. This is typical for a 510(k) summary, which often provides an overview rather than granular test reports.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only refers to "performance testing." Given the nature of this device (a catheter), the "test set" likely refers to samples of the device itself undergoing various laboratory and perhaps animal studies.
Critique: Without this information, it's impossible to assess the statistical validity or generalizability of the testing. For a device like this, the "test set" would primarily be physical units of the device tested under simulated or in vivo conditions, not a dataset of patient images or clinical outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable to the provided document. The device is a physical catheter, not an AI or diagnostic imaging systemrequiring expert interpretation of data to establish ground truth. Ground truth for a physical device would relate to its physical and functional properties, established through engineering measurements and potentially in vivo animal studies or clinical trials with direct observation/measurement.
4. Adjudication Method for the Test Set
This section is not applicable for the reasons stated in point 3.
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 AI-powered diagnostic tools or imaging systems where human readers interpret medical cases. The Endopulmonary Vent is a physical medical device.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done. This is not an AI device.
7. The Type of Ground Truth Used
For a physical device like the Endopulmonary Vent, the "ground truth" for performance testing typically involves:
- Engineering Specifications: Adherence to design requirements for dimensions, material properties, tensile strength, flow rates, pressure resistance, etc.
- Biocompatibility Testing: Ensuring the materials are safe for contact with human tissue and blood (e.g., ISO 10993 standards).
- Sterility Testing: Confirming the device is sterile.
- Functional Testing: Measuring actual performance parameters in vitro (e.g., flow rates through the catheter) and potentially in vivo (e.g., animal studies to assess deployment, positioning, and effectiveness in a physiological setting).
The document broadly refers to "performance testing" but does not detail the specific types of ground truth or testing methods used.
8. The Sample Size for the Training Set
This section is not applicable. This is not an AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the reasons stated in point 8.
Summary of Missing Information and Observations:
The provided text is a summary for a 510(k) submission for a physical medical device (catheter), not an AI algorithm or a diagnostic imaging system. Therefore, many of the requested categories (like sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies) are not applicable or not detailed in this type of summary document. The document focuses on establishing substantial equivalence to predicate devices and broadly stating that performance testing confirmed safety and effectiveness. To get the specific details of performance criteria and testing, one would need to review the full 510(k) submission and associated test reports, which are usually more extensive than this public summary.
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).