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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

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.

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Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of aortic root pressure during cardiopulmonary bypass.

Endoaortic Clamp Catheter

The provided text describes a 510(k) Notification for the Heartport Endoaortic Clamp™, a medical device used for aortic occlusion, cardioplegic solution delivery, and aortic root pressure monitoring during cardiopulmonary bypass.

However, the provided text does not contain any information about acceptance criteria, device performance metrics (e.g., sensitivity, specificity), sample sizes for test sets, data provenance, expert ground truthing, MRMC studies, standalone performance studies, or details about training sets.

The only information provided about testing is:

• Non-clinical Test Results: "Performance testing has demonstrated with 95% confidence that the Heartport Endoaortic Clamp™ will meet or exceed Heartport, Inc. performance standards."
• Test Conclusions: "Performance testing has demonstrated that the Endoaortic Clamp will function safely and effectively, while meeting the anticipated clinical requirements for the intended use."

This is a very high-level statement indicating that the device met internal performance standards, but it does not specify what those standards are, how they were measured, or the details of the study proving it.

Therefore, I cannot populate the requested table or answer the specific questions about the study design, as that information is not present in the provided text. The text focuses on the device's identity, intended use, and equivalence to predicate devices, rather than detailed performance study results.

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Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of aortic root pressure during cardiopulmonary bypass.

Endoaortic Clamp (Catalog Number 02055)

This document does not describe acceptance criteria or a study that proves a device meets them. Instead, it is a 510(k) summary for a medical device (Endoaortic Clamp) and contains the following information:

• Applicant Information: Heartport, Inc.
• Device Information:
  • Trade Name: Endoaortic Clamp (Catalog Number 02055)
  • Common Name: Endoaortic Clamp Catheter
  • Classification Name: Cardiopulmonary bypass vascular catheter
• Equivalent Devices: Heartport Endoaortic Clamp (Catalog Number 01055)
• Intended Use: Occlusion of the aorta, delivery of cardioplegic solution, and monitoring of aortic root pressure during cardiopulmonary bypass.
• Comparison To Predicate Devices: The new device is a preassembled version of the predicate device with necessary accessories in one sterile package.
• Non-clinical Test Results: States that performance testing demonstrated with 95% confidence that the device meets or exceeds Heartport, Inc. performance standards.
• Test Conclusions: States that performance testing demonstrated the device will function safely and efficaciously, meeting anticipated clinical requirements.

The document does not provide the detailed information requested in your prompt regarding acceptance criteria, specific study results, sample sizes, ground truth establishment, or expert involvement. It is a high-level summary.

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Occlusion of the aorta, delivery of cardioplegia, and monitoring of aortic root pressure during cardiopulmonary bypass.

Endoaortic Clamp Catheter

The provided text is a 510(k) summary for the Heartport Endoaortic Clamp Catheter, dating back to 1996. This document is a regulatory submission for a medical device and does not contain the level of detail typically found in a scientific study report, especially concerning acceptance criteria and detailed study methodology as would be expected for modern AI/ML medical devices.

Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance
   The document does not explicitly state quantitative acceptance criteria or performance metrics in a table format. It broadly states the device "successfully maintained cardiopulmonary pass."

   Acceptance Criteria	Reported Device Performance
   Maintain cardiopulmonary bypass (implicit acceptance)	Successfully maintained cardiopulmonary pass in ten subjects
   Function safely and efficaciously	Demonstrated to function safely and efficaciously
   Meet anticipated clinical requirements	Demonstrated to meet anticipated clinical requirements

2. Sample size used for the test set and the data provenance

   • Sample Size: Ten subjects.
   • Data Provenance: The study was a "clinical investigation," implying a prospective collection for this specific device evaluation. There is no information on the country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
   Not applicable (N/A). This device is a mechanical clamp, not an AI/ML diagnostic system. The "ground truth" would be established by direct physiological measurements and clinical outcomes, not expert interpretation of outputs.

4. Adjudication method for the test set
   N/A. As this is not an interpretive diagnostic device, an adjudication method for establishing ground truth is not relevant in the context of expert consensus. Clinical outcomes and physiological parameters would be directly observed.

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
   N/A. This is a mechanical medical device, not an AI-assisted diagnostic tool requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   N/A. This is a mechanical medical device.

7. The type of ground truth used
   The ground truth would be based on direct clinical observation of the device's function during cardiopulmonary bypass in human subjects, including physiological parameters (e.g., maintaining blood flow, pressure monitoring) and patient outcomes. The text states the device "successfully maintained cardiopulmonary pass," implying successful physiological functioning.

8. The sample size for the training set
   N/A. This is not an AI/ML device, so there is no concept of a "training set" in the machine learning sense. The device was likely developed and refined through engineering testing and potentially pre-clinical (animal) studies, but these are not referred to as "training" in this context.

9. How the ground truth for the training set was established
   N/A. See explanation for point 8.

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