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510(k) Data Aggregation
(156 days)
COEUR, INC. FRONTLOAD FOR OPTIVANTAGE POWER INJECTOR
For use in adapting Liebel-Flarsheim Optivantage DH Injectors for use with Coeur Front Load Syringes
The proposed device is a Front Load Adapterfor Liebel-Flarsheim Optivantage DH Injector. As defined by 21 CFR 870.1650, an angiographic injector and syringe is a device that consists of a syringe and a highpressure injector which is used to inject contrast media into the heart, great vessels. and coronary arteries to study the heart and vessels by x-ray photography. The Coeur adapter is a unit designed to install onto legally marketed power injectors to enable use of the Coeur syringe with such injectors. It includes a component that affixes to the ram of the power injector to adapt it to fit the plunger of the Coeur syringe.
Here's a breakdown of the acceptance criteria and the study details for the Coeur, Inc. Front Load Adapter for CT Injector, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The adapter can be properly installed. | Successfully completed. |
| The syringe will properly load into the adapter. | Successfully completed. |
| The syringe, with the adapter, can be filled and used to inject contrast, saline, or other diagnostic fluids into the patient without affecting the function of the power injectors. | Successfully completed. The equipment performed as intended (i.e., injecting contrast, saline, or other diagnostic fluids into patients while allowing the ram to be advanced to move the plunger to the full forward position for filling, similar to the predicate device). |
Study Details
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Sample size used for the test set and the data provenance: Not explicitly stated. The text only mentions "Such testing was conducted for the design for use on the Liebel-Flarsheim Optivantage DH Injectors." This implies a physical, non-clinical test, not a data-driven test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth was established through functional performance testing against pre-defined engineering criteria, not expert review of data.
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Adjudication method for the test set: Not applicable. This was a functional performance test, not a review requiring adjudication.
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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, an MRMC comparative effectiveness study was not done. The device is an adapter for a CT injector, not an AI or imaging analysis device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm. However, the functional performance testing of the adapter itself can be considered "standalone" in the sense that its performance was evaluated intrinsically without a human operator's variable input being the primary focus of the test itself (though a human would have performed the installation/operation for the test).
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The type of ground truth used: Functional performance against predetermined engineering and design requirements for installation, loading, filling, and injection, and ensuring no negative impact on the power injector's function.
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The sample size for the training set: Not applicable. This device is not an AI or machine learning product that requires a training set.
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How the ground truth for the training set was established: Not applicable. No training set was used.
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