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510(k) Data Aggregation
(90 days)
The TEMED Gas Diffuser is intended for use by cardiovascular surgeons in open heart surgery procedures for the insufflation of carbon dioxide gas into the thoracic cavity to reduce the risk of air embolism which can result in organ damage.
The TEMED Gas Diffuser is a disposable surgical device for effective insufflation of carbon dioxide (CO2) into an open surgical wound, which will increase the level of CO2 in the local atmosphere and reduce the risk of air embolism. Air will enter the heart and great vessels during conventional open-heart surgery and can be difficult to evacuate with current de-airing techniques. Trapped air will be mobilized to the arterial vessels during weaning from cardiopulmonary bypass and may result in embolism to the brain and other organs. Since air dissolves poorly in blood and tissue, air bubbles will obstruct blood flow and cause tissue hypoxia and injury. CO2 is 25 times more soluble in blood and tissue than air is. Arterial CO2 emboli will thus be fewer and dissolve more quickly, decreasing the risk of organ injury. Carbon dioxide is 50% heavier than air and will therefore sink to the bottom of the chest cavity, displacing the air as it does so. Air displacement in this way will result in a local atmosphere surrounding the wound of up to 100% CO2.
The TEMED device is formed of the following components; a section of ¼" tubing which can be connected to a regulated, medical grade, CO₂gas source. This piece of tubing features an in-line 0.2μ microbial filter placed 0.50m from the end. This tubing is connected to a further piece of tubing which is smaller in diameter and length. This last section of tubing is malleable, allowing surgeons to place the tip of the diffuser as per the instructions for use. The final component of the TEMED Gas Diffuser is the hydrophobic diffusing tip.
The TEMED Gas Diffuser is intended for use by cardiovascular surgeons in open heart surgery procedures for the insufflation of carbon dioxide gas into the thoracic cavity to reduce the risk of air embolism.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance is based on substantial equivalence to a predicate device, the CarbonAid CO2 Diffuser. Therefore, the acceptance criteria are largely implied by demonstrating equivalent performance to the predicate device.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported TEMED Gas Diffuser Performance |
|---|---|
| Functional Equivalence: Capable of insufflating CO2 into the thoracic cavity. | "The TEMED Gas Diffuser is capable of delivering carbon dioxide into the thoracic cavity as intended." |
| Air Displacement Efficiency: Displaces air sufficiently. | "The Air Displacement Efficiency Test shows that the local atmosphere of CO2 increases sufficiently, displacing air to the same degree as the predicate device." |
| CO2 Delivery Rate: Delivers CO2 at a rate up to 10 l/min. | "Up to 10 l/min" (matching the recommended flow rate of the predicate device). |
| Biocompatibility: Device and components are biocompatible. | "Biocompatibility testing has been performed to ensure that this device and its component parts and materials are biocompatible." |
| Shelf-life Stability: Maintains structural integrity and functionality over shelf life. | "The shelf life validation programme proves that the device's structural integrity and functionality remain during the shelf life of the product." |
| Sterilization Method: Compatible with Ethylene Oxide sterilization. | "Ethylene Oxide" (matching the predicate device). |
| Storage Temperature: Stable within a defined storage temperature range. | "1 — 40°C" (Predicate: 10 - 30°C, implying the TEMED device is stable over a broader range). |
| Safety and Effectiveness: No new questions of safety or effectiveness. | "There is no difference in the safety or effectiveness between the device that TEMED intends to market and the predicate device with respect to the performance of the device." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Performance testing" and a "Gas Delivery Study" and an "Air Displacement Efficiency Test," but does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The performance evaluation focuses on direct measurement of device characteristics rather than expert-derived ground truth for complex clinical outcomes.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of the tests (measuring gas delivery and displacement), an adjudication method for human interpretation of results is unlikely to have been employed in the traditional sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
This is not applicable as the device is a physical medical device (gas diffuser) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of human improvement with AI assistance was not performed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable as the device is a physical medical device and does not involve an algorithm working in a standalone capacity.
7. The Type of Ground Truth Used
For the performance tests described ("Gas Delivery Study" and "Air Displacement Efficiency Test"), the ground truth would be objective, quantitative measurements of CO2 delivery rates, CO2 concentration in the local atmosphere, and potentially air displacement metrics. It does not appear to rely on expert consensus, pathology, or outcomes data in the traditional sense of diagnostic devices.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical medical device and does not involve a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for a machine learning model.
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