(281 days)
The cardiac insulation pad is indicated for use in patients undergoing heart surgery where there is a need to reduce undesirable re-warming of the mvocardium and protect the left phrenic nerve from cold injury during local cooling of the heart.
The Cardiac Insulation Pad is a thin, pliable, foam pad which can be cut to conform to the shape of the heart. The pad covers the posterior cardiac wall or the mvocardium. When the surgeon is finished using the pad, it can be easily removed by pulling the PVC locator tape. The cardiac pad is available in two sizes; adult and infant.
The Cardiac Insulation Pad isolates the myocardium from warmer tissues (descending thoracic aorta, liver, and surrounding pericardial tissues) and thus reduces undesirable re-warming of the myocardium. In addition, it protects the left phrenic nerve from cold injury during local cooling of the heart.
Material: Crosslinked, closed cell polyolefin foam
The Cardiac Insulation Pad is indicated for use in patients undergoing heart surgery where there is a need to reduce undesirable re-warming of the myocardium and protect the left phrenic nerve from cold injury during local cooling of the heart.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Prevention of Left-Sided Diaphragmatic Paralysis (Phrenic Nerve Protection) | Guinn GA et al. study (1990): The cardiac insulation pad "prevented left-sided diaphragmatic paralysis in 52 of 58 patients" (89.7%). |
| Esposito RA, Spencer, FC study (1987): A pericardial insulation pad "prevented diaphragm paralysis in 83% of the patients." | |
| Conclusion: "Thus it was concluded that the cardiac insulation pad protects the phrenic nerve from the cold during heart surgery where the heart is cooled." | |
| Reduction of Undesirable Myocardial Re-warming | The predicate device description (Cardiac Insulation Pad by Shiley, Inc.) also cites this indication. The submitted device states: "The Cardiac Insulation Pad isolates the myocardium from warmer tissues (descending thoracic aorta, liver, and surrounding pericardial tissues) and thus reduces undesirable re-warming of the myocardium." No explicit separate performance metric is provided for this aspect in the 510(k) summary, but its effect is generally implied through the mechanism of insulation. The clinical studies focus on the phrenic nerve, but the overall function of insulation would inherently contribute to reduced re-warming. |
2. Sample Size Used for the Test Set and the Data Provenance
- Guinn GA et al. study: 58 patients. The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated in the 510(k) summary. Given the journal (Texas Heart Institute Journal), it is likely to be US-based, and clinical studies of this nature are typically prospective, but this is an assumption.
- Esposito RA, Spencer, FC study: The number of patients is not explicitly stated in the provided abstract, only "83% of patients." The journal (Annals of Thoracic Surgery) suggests it is a clinical study, likely prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the 510(k) summary. These were clinical studies (likely medical professionals, surgeons, or cardiologists), but the specific number of experts or their qualifications for establishing the outcome (diaphragmatic paralysis) are not detailed.
4. Adjudication method for the test set
This information is not provided in the 510(k) summary. For clinical outcomes like diaphragmatic paralysis, the assessment would typically be made clinically by the treating physicians, but no specific adjudication method (e.g., 2+1, 3+1 consensus) is described.
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
No, a multi-reader, multi-case comparative effectiveness study was not done. This device is a physical medical device (an insulation pad), not an AI/software device that would involve human readers interpreting images or data. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not an AI/software device. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was clinical outcomes data, specifically whether left-sided diaphragmatic paralysis occurred or was prevented, as determined by medical professionals in the context of a clinical study.
8. The sample size for the training set
This is not applicable as this is a physical medical device and not an AI/machine learning algorithm requiring a training set. The studies cited are clinical performance studies, not dataset training.
9. How the ground truth for the training set was established
This is not applicable as this is a physical medical device and not an AI/machine learning algorithm requiring a training set.
§ 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).