(195 days)
The Coeur, Inc. Adapters are for use in adapting CT and/or Angiographic power injectors for use with Coeur syringes.
As defined by 21 CFR 870.1650, an angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material 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. It also includes a plastic lever component that allows the injector to be used more like the existing Mallinckrodt injector and will also be sold separately as a replacement part for that injector.
The provided 510(k) summary for the K070798 device, "Coeur, Inc. Adapters for CT and/or Angiographic Power Injectors," outlines the performance criteria and the testing conducted to demonstrate substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Adapter can be properly installed | Installation was successfully completed. |
| Syringe will properly load into the injector | Loading of the syringe was successfully completed. |
| Syringe can be filled and used to inject contrast, saline, or other diagnostic fluids into the patient without affecting the function of the power injectors | Injection was successfully completed, and the equipment performed as intended (i.e., did not affect the function of the power injectors). |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "Non-clinical Tests Submitted" that involved functional performance verification. It does not explicitly state a numerical sample size (e.g., number of adapters or injection cycles tested).
The data provenance is non-clinical testing performed by the manufacturer, Coeur Medical. The country of origin is not explicitly stated but can be inferred to be the United States, given the submitter's address and the FDA's jurisdiction. The testing was prospective as it was conducted to demonstrate the functional performance of the device for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the 510(k) summary. The "Non-clinical Tests Submitted" section implies internal engineering or quality assurance testing rather than a study involving expert panels to establish ground truth in the context of clinical interpretation or diagnosis. The ground truth for this device's performance is its ability to physically connect and function with existing power injectors and syringes.
4. Adjudication Method for the Test Set:
An adjudication method is not applicable and therefore not described. The testing focused on functional verification (installation, loading, injection) against pre-defined success criteria, which are objective and do not require expert adjudication in the same way clinical image interpretation might.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The device is an adapter, not an interpretative AI tool or a diagnostic imaging system that would benefit from such a study. The purpose of the testing was to demonstrate the safe and effective mechanical function of the adapter.
6. If a Standalone Performance (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, the described "Non-clinical Tests Submitted" can be considered standalone performance testing. The focus was solely on the physical function of the adapter and its interaction with the injector and syringe, without involving human interpretation of results or requiring human interaction beyond operating the equipment to confirm functionality.
7. The Type of Ground Truth Used:
The ground truth used for this device is objective functional performance and successful mechanical integration. This means confirming that:
- The adapter physically fits and can be installed.
- The syringe loads correctly.
- Contrast/saline can be injected without issues, and the power injector's function is not compromised.
This is not "expert consensus," "pathology," or "outcomes data" in the typical sense, but rather a verification of intended mechanical and operational behavior.
8. The Sample Size for the Training Set:
This information is not applicable and therefore not provided. The Coeur, Inc. Adapters are a mechanical device, not an AI or machine learning algorithm that requires a training set. The development of the adapter would involve design, prototyping, and engineering validation, but not "training data" in the computational sense.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for a mechanical adapter. The "ground truth" during the design and development phase would have been engineering specifications, design requirements, and prior knowledge of the power injectors and syringes the adapter is designed for.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.