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510(k) Data Aggregation
(88 days)
COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)
The Coeur Front Load Injector Retrofit Kit is intended to be used with Medrad MCT and MCT Plus Injectors to hold the Coeur 200 mL Front Load Syringe in place in front of the Iniector Ram during the injection of contrast media into the vascular system for diagnostic purposes.
The Coeur Front Load Retrofit Kit consists of two accessory pieces for use with Medrad MCT and MCT Plus Injector Systems and older models of Medrad injectors upgraded by Medrad to resemble the MCT and MCT Plus. The kit contains a face plate and ram tip extension that allow easy use of the Coeur 200 mL Front Load Syringe on the modified versions of Medrad injectors. This premarket notification describes the Coeur Face Plate Retrofit Kit, which is a modification of the Coeur Front Load Injector Turret, which allows use of the Coeur 200 mL Front Load Syringe on older models of Medrad injectors.
The Face Plate uses a standard bayonet mount to attach directly onto the Medrad injectorbase on the MCT and MCT Plus injectors. The ram tip extension is then attached to the existing ram tip and tightened into place to prevent slippage. Once in place, the Coeur 200 mL Front Load Syringe may be used easily on the injectors.
This is a submission for a medical device (injector retrofit kit), not an AI/ML device. Therefore, many of the requested categories (e.g., ground truth, training set, multi-reader multi-case studies) are not applicable.
Here's the information derived from the provided text, focusing on what is relevant for a hardware modification:
Acceptance Criteria and Device Performance for Coeur Front Load Injector Retrofit Kit
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Component Specifications | Components manufactured to specifications. | "Verification data was summarized to demonstrate that the Coeur Front Load Injector Retrofit Kit components could be produced to specification." |
| Simulated Clinical Usage | Performance with Retrofit Kit and Coeur 200 mL Front Load Syringe is equivalent to predicate device (Medrad injector with Coeur Front Load Injector Turret and Coeur 200 mL Front Load Syringe). | "Simulated clinical usage tests showed that a Medrad injector fitted with the Retrofit Kit and the Coeur 200 mL Front Load Syringe performed as well as the Medrad injector fitted with the previously cleared Coeur Front Load Injector Turret and Coeur 200 mL Front Load Syringe." |
Additional Information:
- Sample Size for Test Set and Data Provenance: Not explicitly stated. The text mentions "verification data" and "simulated clinical usage tests" but does not specify the number of units or tests conducted.
- Number of Experts and Qualifications: Not applicable. This is a hardware modification, not a diagnostic or AI device requiring expert interpretation for ground truth.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable as this is a hardware device. No human readers or AI assistance are involved in performance evaluation in this context.
- Standalone Performance (Algorithm only without human-in-the-loop): Not applicable as this is a hardware device. No algorithm is involved.
- Type of Ground Truth Used: The "ground truth" here is the adherence to manufacturing specifications and functional equivalence to a predicate device in simulated use. This is based on physical measurements and functional testing against established benchmarks (predicate device performance).
- Sample Size for Training Set: Not applicable as this is a hardware device and does not involve machine learning.
- How Ground Truth for Training Set was Established: Not applicable.
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