(40 days)
The Heartport Endoaortic Clamp catheter is indicated for use in patients undergoing cardiopulmonary bypass. The Endoaortic Clamp catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.
The Heartport Endoaortic Clamp catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.
The provided 510(k) notification for the Heartport® Endoaortic Clamp™ Catheter does not include specific acceptance criteria or a study that proves the device meets such criteria.
Instead, the submission relies on substantial equivalence to predicate devices. The key statement regarding device performance is:
"Based on the equivalence in design to the predicate device, performance testing was not warranted for this device. The device will meet the same criteria established for the currently marketed Heartport® Endoaortic Clamp™ catheter."
Therefore, most of the requested information cannot be extracted from this document as no new performance study was conducted.
Here's a breakdown of what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document for the new device submission. | No new performance data presented for this submission. |
| Assumed to be the same criteria as the predicate device: Heartport® Endoaortic Clamp™ catheter. | Assumed to meet the same criteria as the predicate device. |
The subsequent questions relate to a performance study, which was explicitly stated as "not warranted" for this device due to its substantial equivalence to a predicate device. Therefore, the answers to these questions are generally "Not applicable" or "Not specified in this document."
2. Sample size used for the test set and the data provenance
- Not applicable. No new performance testing was conducted for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No new performance testing was conducted for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No new performance testing was conducted for this submission.
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
- Not applicable. This device is a medical catheter, not an AI-assisted diagnostic tool, and no performance study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a medical catheter, not an algorithm. No standalone performance study was done for this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No new performance testing requiring ground truth was conducted for this submission. The device's "ground truth" for regulatory purposes is its substantial equivalence to existing, legally marketed devices for which safety and effectiveness have already been established.
8. The sample size for the training set
- Not applicable. This device is a medical catheter, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for a machine learning model is relevant here.
§ 870.4075 Endomyocardial biopsy device.
(a)
Identification. An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.(b)
Classification. Class II (performance standards).