(316 days)
The Heartport QuickDraw venous cannula is indicated for use in patients undergoing cardiopulmonary bypass. The Heartport QuickDraw venous cannula serves to drain nonoxygenated blood from the venae cavae and/or right atrium during cardiopulmonary bvpass.
Not Found
The provided text is a 510(k) summary for a medical device called the Heartport QuickDraw venous cannula. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer most of the requested questions about acceptance criteria and a specific study proving the device meets them.
Here's a breakdown of what can be gleaned and what is missing based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Established specifications | Meets established specifications (details not provided) |
| Biocompatibility | Materials have proven biocompatibility (details not provided) |
Missing Information: The document states that performance testing demonstrated the device meets "established specifications" and that its materials have "proven biocompatibility," but it does not detail what those specific criteria or specifications are, nor does it provide quantitative performance data against them.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document refers to "performance testing" but does not provide any details about the sample size used for the test set, the country of origin, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Missing Information: This information is not present in the provided text. The device is a physical medical device (venous cannula), not an AI/diagnostic tool that would typically require expert-established ground truth for its performance evaluation in the way implied by this question.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: This information is not present. As above, this type of adjudication is usually relevant for diagnostic assessments, not for the physical performance of a cannula.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Missing Information: This is completely inapplicable to the device described. The Heartport QuickDraw venous cannula is a physical device used in cardiopulmonary bypass, not an AI or imaging diagnostic tool that would be evaluated with an MRMC study or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: This question is not applicable to the device described. It is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing Information: Not explicitly stated as the device's performance is likely measured against engineering specifications and relevant ISO standards for medical devices, rather than a diagnostic "ground truth."
8. The sample size for the training set
Missing Information: This is not applicable to the device described, which is a physical medical device and not an AI model requiring a training set.
9. How the ground truth for the training set was established
Missing Information: Not applicable to the device described.
Summary of Study Information Provided in the Text:
The document states:
- "Performance testing demonstrated that the subject device meets established specifications."
- "The materials used in the Heartport QuickDraw venous cannula have proven biocompatibility."
- The overall conclusion is based on "intended use, product performance and biocompatibility information" and establishes "substantial equivalence to currently marketed predicate devices."
However, the 510(k) summary itself (the provided text) does not detail the specifics of this performance testing or biocompatibility assessment, nor does it include information about clinical studies with human subjects or detailed expert evaluations that would be typical for many AI-based or diagnostic devices. The acceptance criteria it refers to are internal "established specifications" and "proven biocompatibility," the details of which are not disclosed in this public summary. This type of submission focuses on demonstrating substantial equivalence to existing devices rather than a de novo detailed clinical efficacy study with specific expert-adjudicated ground truth.
§ 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).